Title: Associate, Quality Assurance
Reports to: Assistant Manager, QA
Job Function
- Perform pharmaceutical batch release and product disposition activities for Canada and US markets.
- Provide QA oversight of pharmaceutical distribution operations and ensure compliance with GMP requirements.
- Support controlled substance handling, reconciliation, and documentation in accordance with applicable regulatory requirements.
- Support post-market quality activities, including product recalls, field alerts, market complaints, and related investigations.
- Maintain RRCL’s Quality System in compliance with Health Canada, USFDA, GMP, and applicable regulatory requirements.
Duties and Responsibilities
- Perform QA review and release of pharmaceutical batches for North American markets.
- Review batch manufacturing records, Certificates of Analysis, specifications, laboratory results, deviations, investigations, CAPAs, change controls, and other release documentation.
- Ensure all required manufacturing, testing, and quality documentation is complete prior to batch disposition.
- Coordinate with Manufacturing, QC, R&D, Supply Chain, and external manufacturers to resolve batch-release issues.
- Provide QA oversight of pharmaceutical manufacturing activities and support manufacturing investigations and quality events.
- Support QPIC/AQPIC activities, including controlled substance handling, inventory reconciliation, documentation, and compliance.
- Support field alerts, product recalls, market complaints, and post-market quality investigations.
- Support root cause investigations and CAPA implementation associated with manufacturing and product quality issues.
- Review and approve GMP documentation, SOPs, batch records, and quality records.
- Perform applicable laboratory data and audit-trail reviews to support batch release.
- Support equipment commissioning, qualification, and validation activities where required.
- Support regulatory, customer, and internal audits and provide documentation related to batch release and manufacturing activities.
- Support DEL and other regulatory compliance activities as assigned.
- Perform other duties as assigned by the reporting manager or Site Quality Head.
Skills and Qualifications
- Bachelor’s degree in pharmacy, Pharmaceutical Sciences, Chemistry, Biochemistry, or related scientific discipline.
- 2–5 years of pharmaceutical industry experience, preferably in Quality Assurance
- Strong experience in pharmaceutical batch release and product disposition.
- Previous experience as a QPIC and/or AQPIC is highly preferred.
- Previous experience in pharmaceutical manufacturing operations is strongly preferred.
- Experience with controlled substances, inventory reconciliation, and regulatory documentation is preferred.
- Experience with field alerts, product recalls, market complaints, and post-market quality activities is preferred.
- Experience with deviations, investigations, CAPA, change controls, and risk assessments.
- Experience with equipment commissioning, qualification, or validation is an asset.
- Knowledge of Health Canada, USFDA, GMP, GDP, and data integrity requirements.
- Strong documentation, technical writing, communication, and problem-solving skills.
- Strong attention to detail and ability to make sound quality decisions under tight batch-release timelines.
