Quality Assurance Pharmacist
About this role
At Excelya, we combine passion, scientific excellence, and collaboration to support our clients throughout the entire drug development lifecycle. We encourage our employees to be bold, take initiative, and unlock their full potential in an international, fast-growing environment.
We are currently looking for a Quality Assurance Pharmacist to strengthen our Quality team and support pharmaceutical quality systems, product quality activities, and regulatory compliance initiatives.
Key responsibilities :
Quality Management System (QMS)
Manage and maintain quality documentation including SOPs, procedures, and quality records.
Coordinate document lifecycle activities, including creation, review, approval, archiving, and periodic reviews.
Support and deliver GxP and quality-related training programs.
Participate in internal audits, supplier audits, and health authority inspections.
Manage quality events including deviations, CAPAs, change controls, and continuous improvement initiatives.
Ensure compliance with applicable pharmaceutical regulations and quality standards.
Product Quality Activities
Manage product quality complaints and associated investigations.
Support quality defect reporting and interactions with health authorities when required.
Conduct risk assessments and quality impact evaluations.
Participate in product recall and shortage management activities.
Review Product Quality Reviews (PQRs) and monitor quality trends.
Review and approve batch release documentation and distribution-related quality activities.
Quality Oversight & Continuous Improvement
Monitor quality KPIs and performance indicators.
Contribute to Management Reviews and Annual Quality Reviews.
Support cross-functional initiativ
Responsibilities
- Manage and maintain quality documentation including SOPs, procedures, and quality records.
- Coordinate document lifecycle activities, including creation, review, approval, archiving, and periodic reviews.
- Support and deliver GxP and quality-related training programs.
- Participate in internal audits, supplier audits, and health authority inspections.
- Manage quality events including deviations, CAPAs, change controls, and continuous improvement initiatives.
- Ensure compliance with applicable pharmaceutical regulations and quality standards.
- Manage product quality complaints and associated investigations.
- Support quality defect reporting and interactions with health authorities when required.
Requirements
- Conduct risk assessments and quality impact evaluations.
- Participate in product recall and shortage management activities.
- Review Product Quality Reviews (PQRs) and monitor quality trends.
- Review and approve batch release documentation and distribution-related quality activities.
- Monitor quality KPIs and performance indicators.
- Contribute to Management Reviews and Annual Quality Reviews.
- Support cross-functional initiativ