Job Opportunities

Description du poste

Mivado GlobalPerformance est à la recherche d’un (e) Consultant(e) Qualité et Conformité Réglementaire qui sera basé à Lomé au Togo.

Le profil recherché est un expert en assurance qualité, chargé d’accompagner nos clients des secteurs pharmaceutique, médical et agroalimentaire dans la mise en place et le maintien de systèmes de management de la qualité robustes. Il/Elle intervient en tant que conseiller stratégique pour garantir la conformité réglementaire de leurs activités, tout en optimisant leurs processus et en réduisant les risques.

Responsabilités principales

• Expertise réglementaire:
  • Maîtriser les réglementations spécifiques aux secteurs pharmaceutique, médical et agroalimentaire (BPF, BPL, normes ISO, etc.).
  • Soutenir nos clients lors des demandes d’homologation et d’autorisation de mise en marché de leurs produits.
  • Effectuer une veille réglementaire continue pour informer les clients des évolutions législatives.
• Audit et évaluation:
  • Réaliser des audits de systèmes qualité, de processus et de produits/services.
  • Évaluer la conformité aux normes et réglementations en vigueur.
  • Identifier les écarts et les opportunités d’amélioration.
• Conseil stratégique:
  • Accompagner les clients dans la définition et la mise en œuvre de leur stratégie qualité.
  • Proposer des solutions personnalisées pour répondre aux enjeux spécifiques de chaque client.
  • Assister les clients dans la préparation aux audits réglementaires.
• Formation et accompagnement:
  • Former les équipes des clients aux bonnes pratiques qualité et aux exigences réglementaires.
  • Accompagner les clients dans la mise en place d’actions correctives et préventives.
• Documentation:
  • Élaborer des procédures, des modes opératoires et des documents qualité.
  • Rédiger des rapports d’audit et des plans d’amélioration.

Profil recherché

• Formation:
  • Formation de niveau minimum Bac +5 idéalement
  • Diplôme universitaire en sciences de la vie, ingénierie, qualité ou équivalent.
• Expérience:
  • Expérience significative dans le domaine de la qualité et de la conformité réglementaire dans au moins un des secteurs visés (pharmaceutique, médical, agroalimentaire).
  • Minimum de 0-3 années d’expérience dans un rôle similaire.
  • Connaissance approfondie des normes et réglementations applicables (BPF, ISO 9001; ISO 13485; HACCP; FSSC 22000; etc.)
• Compétences:
  • Capacités d’analyse et de synthèse.
  • Excellentes qualités de communication écrite et orale.
  • Sens de l’organisation et rigueur.
  • Aptitude à travailler en équipe et en autonomie.
  • Maîtrise des outils informatiques (suite Office, logiciels de gestion de la qualité).
• Qualités personnelles:
  • Sens du service client et capacité à établir des relations de confiance.
  • Pédagogie et capacité à expliquer des concepts techniques.
  • Adaptabilité et proactivité.

Atouts supplémentaires

• Expérience en audit: Certification d’auditeur interne (ISO 9001, ISO 13485; HACCP; FSSC 22000).
  • Connaissance de plusieurs langues: Anglais courant obligatoire, toute autre langue (allemand, espagnol, Mandarin) serait un plus.
  • Expérience en gestion de projets.

Job Description

Mivado GlobalPerformance is seeking a process/chemical Engineer to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.

Responsibilities

You will participate in design and process engineering activities for medium and large-scale projects. You will provide technical solutions in compliance with the applicable standards in force and will have the following responsibilities in particular:

• Participate in project definition;
• Analyze client needs to determine the optimal process to use;
• Perform mass and energy balances;
• Design and specify equipment (Single Use) and process installations (pumps, heat exchangers, control valves, piping, and instrumentation, etc.);
• Calculate process utility requirements (steam, chilled water, compressed air, etc.);
• Prepare and execute technical plans and specifications;
• Review and approve technical deliverables and the design of PFD and P&ID process diagrams;
• Participate in risk analyses (HAZOP or others);
• Establish project budgets and schedules;
• Coordinate the installation, start-up, validation, and maintenance of process equipment;
• Collaborate with the interdisciplinary project team;
• Follow up with suppliers, contractors, and customers.

Skills and Experience

• Engineer degree in chemical or biotechnology engineering or other relevant specialty;
• 2 to 5 years of experience, preferably in the chemical or industrial industry;
• Knowledge of norms and standards (ISPE Guides; ASME-BPE);
• Experience in consulting engineering (asset);
• Factory experience;
• Knowledge of CAD software such as AutoCAD;
• Experience with process simulation software such as Superpro Designer, Aspen Hysys, Pipe-Flo, HTRI; etc

Required Skills

• Excellent communication and leadership skills;
• Openness & positive attitude
• Proactivity and autonomy
• Striving for excellence;
• Sense of organization and rigor;
• Technical know-how;

Additional Information

We are an equal opportunity employer.

Mivado GlobalPerformance is seeking a Specialist in process/chemical engineering to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any type of bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.

Responsibilities

• Works safely by EHS guidelines and adheres to Client cGMP Quality Management System requirements.
• Becomes subject matter expert (SME), remains trained and qualified in the area of expertise, and displays initiative in personal development opportunities further to enhance skills and expertise relevant to the position.
• Provide SME troubleshooting/oversight and support execution of the batch as needed to deliver the site key performance indicators of Right First Time and On Time Delivery.
• Builds partnerships and works collaboratively with the Operations Managers in mentoring Operations staffs with a focus on building talent depth and demonstrating positive behaviors as per company core values.
• Support operational production and facility maintenance planning as well as the transfer of new technologies/procedures/equipment to Operations to address production demands as per S&OP.
• Review manufacturing batch records, standard operating procedures, logbooks, or validation protocols required for Phase III projects as per ICH guidelines.
• Assists Operations group with deviation investigation and determination/implementation of preventative/corrective actions.
• Ensure audit readiness within Operations by identifying and addressing gaps as well as preparing storyboards and providing SME input during audit.
• Drive continuous improvement in Operations.

Skills and Experience:

• Must have at least 2+ yrs’ cGMP experience and technical expertise in Upstream and/or Downstream Processing.
• Have excellent written & verbal communication skills.
• Ability to work unsupervised, under pressure on multiple tasks and manage priorities independently.
• Possess strong organizational and planning skills and a commitment to excellence.
• Preferred to be educated to minimum Degree level in Biology, Chemistry or related field.
• Sufficient knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams.
• Use of DeltaV, Dynamic 365, MasterControl, eDMS, Trackwise, SAP.

Additional Information

We are an equal opportunity employer.

Mivado GlobalPerformance is looking for a Specialist in process/chemical engineering to join our Industrial design team to support the engineering, design, commissioning, qualification, and startup of upstream and downstream bioprocess systems/equipment in various consumer goods/food/beverage/chemical markets. In this role, you will lead conceptual and detailed design efforts on key projects, train and mentor other junior engineers, and resolve design problems. We strongly encourage chemical engineers/process engineers with any type of bioprocessing/biomanufacturing/industrial large-scale fermentation experience to apply.

Responsibilities

• Provide technical guidance into the design, project management, commissioning, and start-up of equipment and facilities, for upgrades, renovations, and expansions of client facilities and processes.
• Support project execution from Feasibility through to project completion/handover, including all project stages such as:
  • Feasibility
  • Concept Design, Basic Design, Detailed Design
  • Procurement
  • Construction
  • Project Monitoring/Governance
  • Commissioning & Qualification
• Prepare/perform/review process engineering drawings, and calculations, whether as part of engineering design or as part of verification of calculations of vendors/clients/other consultants. Drawings may include PFDs, P&IDs as well as others. Calculations may include heat exchanger, pump, piping, control valve sizing, heat, and mass balances, as well as other engineering calculations.
• Prepare/review technical specifications and data sheets for various equipment, instrumentation, and systems (such as vessel data sheets, etc).
• Review technical documentation such as SDS/HDS, layouts, manuals, and datasheets.
• Manage other engineering design firms, equipment vendors, construction firms, and internal/external stakeholders as required to execute projects.
• Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).
• Prepare/review User Requirements Specifications (URS)
• Provide input into Commissioning (FAT, SAT) and Qualification Protocols (IQOQ), as well as support execution of Commissioning & Qualification.
• Prepare/review automation sequences, as required for Process Automation, such as Functional Specifications, Valve & Alarm Matrices.
• Coordination with other engineering disciplines and other cross-functional departments (automation engineering, facilities engineering, process engineering, validation, project management, operations, quality, safety).
• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Travel may be required for meetings with, clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• As this position requires working on client sites, you will need to comply with the client’s safety rules including mandatory vaccination policies for COVID-19, where applicable.
• Visit construction and installation sites.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Other duties as assigned by the client, based on workload and project requirements.

Qualifications

• Ability to lift 50 lbs.
• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience:
  • 3+ years of process engineering experience in pharma/biotech or in core biopharmaceutical unit operations (upstream or downstream).
• Knowledge of GMP requirements for working in pharma/biotech facilities, with a Basic understanding of SOPs, Validation, and Change Controls.
• Experience with, and knowledge of some of the typical Biotechnology processes & peripheral systems is required; Upstream Biotech Processes (Fermentation, Bioreactors, Centrifugation, Thawing), Downstream / Purification Biotech Processes (chromatography, TFF, DF, NF-MF), Fill & Finish equipment, Media Preparation, CIP/SIP systems, Buffer Preparation, clean utilities (PW, WFI, CS, PS)
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Basic knowledge of AutoCAD is an asset.
• Engineering degree, preferably in Chemical, Biochemical, Mechanical Engineering or a related discipline.
• French Fluency is a must

Additional Information

We are an equal-opportunity employer.

Nous sommes à la recherche d’un(e) Conseiller(ère) en Assurance qualité pour aider à maintenir les normes de système qualité élevées de nos clients oeuvrant dans le domaine de production du cannabis.

Votre mission sera d’agir comme référence en matière de contrôle qualité au sein de notre équipe où tu auras la responsabilité de faire évoluer la culture qualité de l’entreprise.

Responsabilités principales :

• Planifier, mettre en place et maintenir un système de gestion de la qualité en accord avec les normes et réglementations de Santé Canada
• Assurer la conformité des procédures de production, des pratiques de laboratoire et de la documentation
• Coordonner les audits internes et externes en matière de qualité et participer à la gestion des évaluations de conformité
• Collaborer avec les équipes de production pour résoudre les problèmes de qualité et recommander des solutions pour améliorer les processus
• Élaborer et dispenser des formations pour les employés afin de s’assurer que les normes de qualité sont bien comprises et respectées
• Gérer les systèmes de traçabilité pour suivre les produits de leur point d’origine à leur destination
• Assurer la conformité des étiquettes des produits avec les exigences réglementaires de Santé Canada
• Maintenir et mettre à jour les documents relatifs à l’assurance qualité
• Participer à la gestion des plaintes des clients et à l’investigation des problèmes de qualité
• Être la référence en assurance qualité
• Être un acteur de changement et d’innovation pour la vision de l’assurance qualité
• Assurer une excellente collaboration avec les parties prenantes

Qualifications requises :

• 3+ année d’expériences en qualité, conformité ou affaires réglementaires, sécurité alimentaire et/ou domaine connexe
• Bac en sciences, chimie, agroalimentaire dans un programme lié à la qualité, la réglementation, la sécurité alimentaire ou tout autre domaine connexe
• Connaissance des normes et réglementations de Santé Canada
• Expérience préalable en assurance qualité, de préférence dans le secteur pharmaceutique, du cannabis ou de la production alimentaire
• Excellentes compétences en communication écrite et verbale en français et en anglais
• Capacité à travailler de manière autonome et en équipe
• Capacité à résoudre les problèmes de manière créative
• Capacité à gérer plusieurs projets simultanément et à respecter les échéances
• Capacité à maintenir des normes élevées de confidentialité et d’intégrité

Conditions de travail

• Bilingue: Français et Anglais
• Travail en entreprise et télétravail (mode Hybride)
• Être disponible à voyager occasionnellement

Description

The Quality Control Specialist will act as a Consultant and is responsible for planning and executing Quality Control deliverables while overseeing and evaluating the work performed by pharma product supplier and providing mentoring to our customer Quality staff. This role requires advanced knowledge and experience in QA, QC, Validation, Health Canada and FDA regulations, laboratory standards and industry standards for pharmaceutical production and Supplier facility with a strong understanding of GMP.

Principal Duties and Responsibilities :

Annual Product Review Program

• Establish and execute APR Program in collaboration with all relevant GMP controlled functions
• Execute and maintain Annual Program Schedule and ensure adherence to the assigned timelines for customer and CMO manufactured products
• Drive an effective assessment of the products compliance overview, identify concerning trends and issues
• Ensure communication with the product owner and supplier of the identified issues and an oversight of the Corrective and Preventive Actions associated with the outcome of the APR Program reflecting CAPA effectiveness in the next year APR
• Employ an effective electronic solutions for optimization of the data consolidation towards APR execution

Change Control Management Program

• Initiate and approve Change Management process at the supplier site as per Quality Policy requirements
• Ensure appropriate Change ownership and timely execution of the Change Control records with the customer and the supplier
• Design and develop Change Management training for the key Change Owners from GMP regulated functions
• Support design and development of the robust electronic solution supporting the Program effectiveness
• Consult the functions on the change management, execution and risk-based impact assessment process

Stability Program

• Lead all the activities associated with management of the Stability Program at the customer site
• Manage development of the Stability Program Protocols and Reports
• Ensure timely placement and retrieval of the samples from the stability chambers and their transfer to the QC testing laboratories
• Manage Stability Program Database
• Consistently strive towards improvement of the Stability Program effectiveness
• Ensure that the customer is compliant to the processes associated with Documentation management and control ( Test Methods, Specifications, SOPs etc.).
• Ensure harmonization of processes and best practice of Quality Systems between our customer and the supplier
• Oversee the review and trending of Quality Metrics, including the monitoring and reporting of Key Performance Indicators
• Participate in Internal, Customer, Supplier and Regulatory Audits
• Develop SOPs as required
• Other duties as assigned

Knowledge, Skills and Abilities

• Minimum of B.Sc. Chemistry or other associated field
• Minimum 5 years’ experience in the pharmaceutical industry
• Member of Ordre des chimistes du Québec
• Experience in Regulatory inspection management
• In depth knowledge of the pharmaceutical industry
• In depth of GMP, FDA, HPFBI Regulatory requirements and the associated guidelines
• Excellent organizational skills and multi-tasking ability
• Excellent written and verbal skills
• Demonstrated ability to work in a team environment
• Excellent interpersonal and negotiating skills
• Experience in dealing directly with Regulatory Agency officials (Health Canada, USFDA)
• Sound knowledge and application of Health Canada and FDA regulations
• Strong statistical, trending and risk analysis skills

Working Conditions

• Bilingual : French and English
• Working Onsite and Remotely
• Must be available to travel occasionally

Job Summary

The Compliance and Quality Assurance Specialist will act as a Consultant and is responsible for planning and executing Quality Assurance deliverables while overseeing and evaluating the work performed by the pharm product supplier and providing mentoring to the Quality Assurance staff. This role requires advanced knowledge and experience in API and CMO quality assurance, Health Canada and FDA regulations, laboratory standards and industry standards in the API production and CMO facility with a strong understanding of GMP.

Areas of Responsibilities

• Review and execute Quality Management Systems (QMS)
• Develop and manage policies, procedures, work instructions, Deviation, CC and CAPA
• Investigate quality concerns; resolve and follow-up on corrective actions
• Monitor, evaluate quality indicators, QA reports and audit responses
• Submit change notification/application to applicable authority
• Set specifications foe substance, materials and intermediates
• Perform in-process and Batch review
• Prepare reports on OOS, critical deviation
• Provide test procedure, quality statements, stability reports, and other documents
• Perform annual Product Quality Review (APQR)

Qualification

• A degree in Chemistry, Biology, Pharmacology or Food Science
• Member of Ordre des chimistes du Québec
• 3+ years experience in Quality Assurance/Control in GxP Regulated industries
• Strong knowledge of GMP, QMS, QRM, Lean Manufacturing & Validation Principles

Working Conditions

• Bilingual : French and English
• Working Onsite and Remotely
• Must be available to travel occasionally

Responsibilities

As a Qualification Validation Specialist, you will act as a Consultant on a remote and/or hybrid mode engagement opportunity.

Duties and responsibilities include, but are not limited to:

• Creating qualification (IQ/OQ/PQ) test protocols.
• Ensuring documentation aligns with URS and PPQ plan.
• Preparing and executing validation documents.
• Project execution for multiple systems validation.
• Understanding the hours budgeted for completion of each task on a specific.
• Individuals must represent the company and division at client sites and interact confidently with clients, contractors, management and peers.
• Develop Installation, Operational and simple Performance qualification documents.

Requirements

• Qualified candidates will possess a Bachelor’s degree in related field along with 3 plus years related industry experience.
• Candidates must have excellent verbal communication and technical writing skills.
• Experience in executing protocols including systems such as Process Validation, computer controlled systems validation, utilities, manufacturing equipment such as computer controlled filling systems, formulation systems and basic knowledge of laboratory validation (not required but preferred).
• Familiarity with many aspects of validation is expected.
• Strong understanding GxP (US FDA, Health Canada, EMA, etc.) requirements
• Experience with temperature mapping.
• Proficient in Microsoft Word, Excel, Power Point and Project.
• Must be willing to travel

Working Conditions

• Bilingual : French and English
• Working Onsite and Remotely
• Must be able to travel occasionally

The Computerized System validation Specialist has primary responsibility for the completion of all phases of assigned automation and computer system validation activities ensuring full compliance to regulatory standards and our client requirements.

Responsibilities

Actively completing, coordinating and managing all phases of assigned automation and computer system validation projects and related activities including but not limited to:

• Development of project plans to support computerized system validation planning;
• Development, review and/or approval of specification and verification documents as per CSV lifecycle documentation and deliverables;
• Development, support and facilitation of change management process for computer and automation systems;
• Analyze and perform assessments using a GAMP risk-based approach for changes on validated computerized systems impacting data integrity, hardware interactions and security, and assign appropriate levels of validation accordingly;
• Provides coaching and mentoring to the organization staff regarding CSV, SDLC, data integrity, security standards, regulations, guidance and best practices;
• Develops and maintain risk management documentation including software risk assessments;
• Evaluates and define computer system validation approach for applicate software or GxP computerized systems;
• Authors validation project plans, protocols, reports and compiles final validation report summaries as required to meet qualification and validation objectives;
• Evaluates and analyzes qualification/validation data collected while verifying acceptability of the data and compliance with the protocol;
• Conducts validation discrepancy investigations; identifies and implements effective root cause analyses and corrective actions;
• Interacts regularly with project team members and influences overall scope development and communicates with all levels of employees within and outside the team;
• Reviews qualification/validation packages for completeness and accuracy, compliance with policies, procedures and accurate data analysis related to computer system;
• Performs a periodic review of qualified and validated software and computer systems as per corporate procedures;

Requirements

• At minimum, must have a University degree (BSc) in Chemistry, Biochemistry or Microbiology or Bachelor’s degree in Engineering;
• 6+ years’ experience in computer system validation in GxP Regulated environment
• Direct experience with manufacturing operations and biotechnology processes is required.
• Strong organizational skills, excellent writing and communications skills
• Experience with basic applied statistical models a plus
• Knowledge of Industry guidelines (ISPE especially GAMP 5, PDA), US and international regulations (FDA, ICH, ISO, EU, Health Canada) for GMP regulated environments
• Excellent verbal and written communication skills
• Project Management experience
• French Fluency is a must

Additional Information

We are an equal-opportunity employer.

Digital Compliance Specialist will be a key player in our client’s Digital Compliance Projects in the regulated industries:

This position involves leading Digital compliance and validation activities often working cross-functionally with various department to ensure quality is met using a risk-based approach. If you are an experienced, result-driven leader, with extensive validation experience, this is the role for you! This is a full-time, permanent position in a growing consulting company with a great culture and environment that supports personal and professional growth.

Responsibities

• Development of project plans to support computerized system validation planning
• Development, review and/or approval of specification and verification documents as per CSV lifecycle documentation and deliverables
• Development, support and facilitation of change management process for computer and automation systems
• Analyze and perform assessments using a GAMP risk-based approach for changes on validated computerized systems impacting data integrity, hardware interactions and security, and assign appropriate levels of validation accordingly
• Evaluate testing procedures for continuous monitoring
• Investigate direct compliance issues
• Assess product, compliance, or operational risks and develop  risk management strategies
• Identify compliance issues that require remediation
• Communicate written policies and procedures across the organization
• Collaborate with senior management and the appropriate department heads
• Advise senior management and business partners about implementing compliance programs
• Review continuous monitoring and continuous documentation of systems
• Report compliance violations

Requirements

• B.Sc. in Engineering, Microbiology, Chemistry, Biotechnology or Biochemistry, or related scientific background
• 5-10+ years’ experience in Life Sciences/Regulated Industry compliance
• Project management certification (an asset)
• Lean Six Sigma certification (an asset)
• Strong Compliance experience (quality, CSV, DI, Annex 11, 21 CFR Part 11) in GxP regulated environment
• Excellent written and verbal communications (English and French), and strong interpersonal skills.
• Autonomous and able to work independently
• Confidence and ability to professionally present information to internal and external stakeholders.
• Project coordination/management expertise
• Attention to detail in the planning and monitoring of actions to carry out the tests and resolve the problems encountered
• Excellent problem solving and root cause researching skills

Additional Information

We are an equal opportunity employer.