Job description

RESPONSIBILITIES

Primary

1. Lead and manage the Quality Assurance team, including scheduling, training, mentoring, and performance evaluation.
2. Act as the primary escalation point for quality-related issues and report quality performance metrics to senior management.
3. Provide leadership for the OTC project by preparing, reviewing, and approving regulatory and GMP-required documentation.
4. Approve and control Master Manufacturing Records (MMR), Master Batch Records (MBR), Packaging Batch Records (PBR), product specifications, Certificates of Analysis (COAs), and procedures for Food, NHP, and OTC products.
5. Authorize the release or rejection of finished products (Food, NHP & OTC).
6. Approve product rework, returns, and recalls in compliance with regulatory and company standards.
7. Maintain and oversee document control systems, ensuring compliance with GMP and regulatory requirements.
8. Oversee the CAPA program, including investigations, root cause analysis, corrective actions, and effectiveness checks.
9. Manage customer complaint investigations, ensuring thorough resolution, trend analysis, and preventive measures.
10. Collaborate with Production, QC, Regulatory, and Sanitation teams to maintain integrated quality operations.
11. Lead and support third-party audits, prepare audit reports, and ensure compliance with external standards (Health Canada, FDA, NSF).
12. Prepare/Supervise, negotiate, and approve Quality Agreements with clients and contracted service providers.
13. Lead environmental monitoring, cleaning validation, and dirty hold time validation processes.
14. Oversee validation and calibration activities for equipment and systems.
15. Support client onboarding activities with QA-related requirements in partnership projects.
16. Approve and support vendor qualification for Chemical Control and Pest Control programs.
17. Supervise sanitation team activities, including scheduling, training, and GMP compliance.
18. Develop, implement, and maintain sanitation programs, ensuring proper cleaning, sanitization, and documentation.
19. Conduct inspections and audits of sanitation practices, ensuring compliance and corrective action implementation.
20. Oversee sanitation supplies and equipment inventory, ensuring proper storage and usage.
21. Drive continuous improvement of departmental processes, systems, and compliance programs.

Additional

1. Participate in the Company’s health & safety program.
2. Report equipment malfunctions, deviations, and quality issues immediately.
3. Provide suggestions for process and system improvements.
4. Support preparation and participation in external audits and inspections.
5. Participate in planning and execution of departmental objectives, ensuring alignment with project goals, regulatory requirements, and timelines.
6. Perform other related duties as assigned by management.

REQUIREMENTS

Knowledge

1. Hold a university degree or equivalent in a science related to the work being carried out.
2. Have practical experience in their responsibility area.
3. Trained in Good Manufacturing Practices (GMP).
4. Knowledge of NHPD Regulations.
5. Knowledge of test procedures, knowledge of pharmaceutical equipment operation, including tablet press, capsule filler, bottling line.

Skills

1. Willingness to learn.
2. Basic proficiency using project management tools.
3. Basic proficiency in mathematics (adding, subtracting, multiplying & dividing).
4. Basic proficiency in using computers.
5. Basic proficiency in using the Microsoft Suite (Word, Excel, PowerPoint, Outlook).
6. Excellent attention to detail.
7. Strong time management.
8. Strong verbal and written communication.
9. Good external client service.
10. Good internal client service.
11. Strong influencing of both colleagues and leadership.
12. Strong in leading others.
13. Excellent in working with people and relationship building.

Abilities

1. Lift a minimum of 25 kg.
2. Work independently on assigned duties.
3. Balance a variety of competing priorities while meeting deadlines.

HEALTH

1. Must be in good health with no communicable diseases or dust allergies.
2. Must wear approved non-slip safety shoes.
3. Must follow appropriate gowning procedure before going into production area.
4. Follow health & safety regulations