What you'll do
- Assist in preparation, review, issuance, distribution, and archival of quality documents including SOPs, forms, specifications, and work instructions
- Maintain document control systems ensuring only current, approved documents are used
- Support review of Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated compliance documentation
- Assist administration of the Quality Management System (QMS) including deviations, CAPAs, change controls, customer complaints, and non-conformance records
- Track quality events to ensure timely investigation and closure
- Support data collection and preparation of quality metrics and reports
- Perform routine GMP inspections of manufacturing, packaging, warehouse, and laboratory areas
- Report quality or compliance concerns to QA Supervisor or Quality Lead
- Coordinate GMP and quality-related training records
- Monitor employee training compliance and maintain training documentation
- Assist onboarding new employees on quality procedures
- Support internal, supplier, and regulatory audits and inspections
- Assist in preparing audit documentation and tracking corrective actions
- Ensure quality records are readily available during inspections
- Assist with documentation for equipment qualification, process validation, cleaning validation, and computerized system validation
- Maintain validation files with complete and current documentation
- Maintain accurate and organized quality records
- Participate in continuous improvement initiatives to enhance quality systems and compliance
- Collaborate with Manufacturing, Quality Control, Warehouse, Procurement and Operations departments
Key requirements
- 2+ years' experience
- Quality Management System (QMS) administration
- Good Manufacturing Practices (GMP) inspections experience
- Document control systems management
- Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) review
- Quality metrics and reports preparation
- Training compliance monitoring and documentation
- Audit support for internal, supplier, and regulatory inspections
- Corrective and Preventive Actions (CAPAs), deviation, change control, customer complaints, and non-conformance management
- Equipment qualification documentation and process, cleaning, computerized system validation
- Collaboration with cross-functional departments
- Pharmacy / Chemistry / Biology / Chemical Engineering / Biochemistry / Relevant Fieldspreferred
Benefits
- Chances for personal and professional growth;
- open, dynamic workplace;
- inclusive and diverse employer committed to equal opportunity.
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 review of Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), and associated documentation for compliance
- Assist in the administration of the Quality Management System (QMS), including deviations, CAPAs, change controls, customer complaints, and non-conformance records
- Track quality events to ensure timely investigation and closure
- Support data collection and preparation of quality metrics and reports
- Perform routine GMP inspections of manufacturing, packaging, warehouse, and laboratory areas
- Report quality issues or compliance concerns to the QA Supervisor or Quality Lead
- Coordinate GMP and quality-related training records
- Monitor employee training compliance and maintain training documentation
- Assist in onboarding new employees regarding quality procedures
- Support internal audits, self-inspections, supplier audits, and regulatory inspections
- Assist in preparing audit documentation and tracking corrective actions
- Ensure quality records are readily available during inspection
- Assist with documentation for equipment qualification, process validation, cleaning validation, and computerized system validation
- Maintain validation files and ensure documentation is complete and current
- Maintain accurate and organized quality records
- Participate in continuous improvement initiatives to enhance quality systems and compliance
- Collaborate with Manufacturing, Quality Control, Warehouse, Procurement and Operations departments
Set yourself apart
You possess the following qualifications, background and abilities:
Bachelor’s degree (Pharmacy, Chemistry, Biology, Chemical Engineering, Biochemistry and relevant fields)
2+ years experience is preferable
Excellent written and verbal communication skills
Fluent in English
What's on offer?
At Fagron, you’ll find plenty of chances to grow — both personally and professionally. We work in an open, dynamic environment where your ideas and talents can shine.
We’re proud to be an equal opportunity employer. 🌍 Diversity makes us stronger, and we’re committed to creating an inclusive workplace where everyone feels welcome.




