QC Manager - Pharmaceuticals

Summary

The position of QC Manager includes, but is not limited, to leading the QC team to perform routine chemical, physical, and microbiological testing and ensure compliance with all aspects of GMP regulations as required by Health Canada, the US FDA and corporate contractual commitments. This includes but is not limited to the unique requirements required for pharmaceutical GMP compliance.

Responsibilities and Duties

• Direct and lead the QC team to perform routine chemical, physical, and microbiological testing of pharmaceutical and nutraceutical materials/ingredients, formulations and finished products.
• Ensure all analytical results and documentations are generated of high quality in a timely fashion along with data integrity traceability requirements.
• Participate in Analytical Investigations of out-of-specification, examine results, change control requests when necessary, generate deviation reports, root cause determination, and provide recommendation for corrective actions.
• Ensuring corporate compliance with GMP regulations as required by Health Canada, the US FDA or other jurisdiction with a focus in maintaining the corporate GMP Establishment License (or other legal licenses).
• As required, provide assistance with internal GMP and third party Audits.
• Coordinate and perform test method development and test method validation.
• Review, and when required act as a backup, to approve certificates of analysis, stability summary reports, calibration reports, analytical monographs, master batch records and packaging records in compliance with legal regulatory and customer requirements.
• As required, develop and update policies and SOPs related to GMP regulations.
• Provide assistance and technical support for equipment or process optimization, validation, calibration, qualification or certification.
• Collaborate with other departments to resolve quality-related issues.
• Lead and train quality control teams.
• Participate in other tasks that may be assigned by the President & CEO.

Qualifications and Skills

• A Canadian (or assessed as equivalent) B.Sc. degree in an applicable discipline of science (chemistry, biochemistry, biology or related) or specific medical training (pharmacology, pharmacokinetics, nutritional research or related).
• Five or more years of QC management experience in the pharmaceutical, nutraceutical or related industry.
• Advanced knowledge of GMP and US FDA regulations for manufacturing pharmaceutical or nutraceutical products.
• Familiarity with laboratory equipment (e.g. HPLC, GC, and ICP).
• Proven ability to supervise personnel and excellent verbal/written communication skills.

Job Types: Full-time, Permanent

Pay: $80,000.00-$100,000.00 per year

Benefits

• Dental care
• Extended health care
• Vision care

Application question(s):

• Can you describe your experience with quality control manager.
• Describe your experience hosting or participating in regulatory audits (e.g., FDA, Health Canada).
• Explain your experience with the validation of analytical methods (e.g., HPLC, GC) according to ICH guidelines

Work Location: In person