What you'll do
- Prepare, review, issue, distribute, and archive quality documents
- Maintain document control systems and ensure only current, approved documents are used
- Review Batch Manufacturing Records, Batch Packaging Records, and related documentation for compliance
- Administer the Quality Management System, including deviations, CAPAs, change controls, complaints, and non-conformances
- Track quality events through investigation and closure
- Collect data and prepare quality metrics and reports
- Perform routine GMP inspections across manufacturing, packaging, warehouse, and laboratory areas
- Report quality issues and compliance concerns to QA leadership
- Coordinate GMP and quality training records
- Monitor employee training compliance and maintain training documentation
- Support employee onboarding on quality procedures
- Support internal, self-, supplier, and regulatory inspections
- Prepare audit documentation and track corrective actions
- Ensure quality records are available during inspections
- Support equipment and process, cleaning, and computerized system validation documentation
- Maintain complete, current validation files
- Maintain accurate, organized quality records
- Participate in initiatives that improve quality systems and compliance
- Collaborate with Manufacturing, Quality Control, Warehouse, Procurement, and Operations
Key requirements
- Good Manufacturing Practice (GMP) and Quality Management Systems
- Document control, batch record review, and validation documentation
- CAPA management, deviation management, and change control
- Quality inspections, internal auditing, supplier auditing, and regulatory inspection support
- Quality metrics and reporting, training compliance management, and English language proficiency
- Pharmacy / Chemistry / Biology / Chemical Engineering / Biochemistry / Relevant Fields
About the job
- Assist in the preparation, review, issuance, distribution, and archival of quality documents, including Standard Operating Procedures (SOPs), forms, specifications, and work instructions - Maintain document control systems and ensure only current, approved documents are in use - Support the…
About the company
Fagron is the world’s leading personalized medicine company and offers prescribers, pharmacists and patients the broadest possible range of therapeutic options. As the market leader, we act locally and think globally. By recruiting the best minds, we aim to strengthen our leading position.
About the company
Fagron is the world’s leading personalized medicine company and offers prescribers, pharmacists and patients the broadest possible range of therapeutic options. As the market leader, we act locally and think globally. By recruiting the best minds, we aim to strengthen our leading position.