Your Trusted 24 Hours Service Provider!
Mivado GlobalPerformance
  • Number #1 Provider
    of Industrial Solution
  • Professional Certification
    Lean Six Sigma Black Belt | Project Management (PMI)
  • Quebec , Canada
    Certified Trainer
Full-Time, Hybrid
Center of Quebec, QC, Quebec, QC
Posted 11 months ago

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

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

Full-Time, Onsite
Montreal, QC, Toronto, ON
Posted 1 year ago

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 Features

Job CategoryContract

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 …

Onsite, Part-Time, Remote
Toronto, ON
Posted 1 year ago

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

Job Features

Job CategoryContract

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 faci…

Full-Time, Onsite, Remote
Center of Quebec, QC
Posted 1 year ago

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

Job Features

Job CategoryContract

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 …

Full-Time, Onsite
Quebec, QC
Posted 1 year ago

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 plus

Additional Information

We are an equal opportunity employer.

Job Features

Job CategoryContract

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 r…

Part-Time, Remote
Quebec, QC
Posted 1 year ago

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.

Job Features

Job CategoryContract, Temporary

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…