Quality Control Specialist

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