What you'll do
- Lead and mentor the Quality team to achieve quality objectives
- Maintain and continuously improve the Quality Management System (QMS)
- Develop and maintain quality systems, processes, and procedures
- Monitor quality throughout the production or delivery lifecycle
- Conduct root cause analysis and implement Corrective and Preventive Actions (CAPA)
- Review quality metrics, prepare reports, and present findings to management
- Ensure compliance with industry standards, customer requirements, and GMP guidelines
- Plan and conduct internal quality audits
- Collaborate with relevant teams to resolve quality issues and complaints
- Identify process improvement opportunities using quality tools
- Manage customer complaints, non-conformance reports, and corrective action tracking
- Develop and deliver quality training programs
- Drive continuous improvement and quality excellence
- Prepare the site for regulatory inspections and customer audits
- Support responses to audit observations and corrective action implementation
- Oversee investigations into deviations, non-conformances, complaints, and OOS results
- Review and approve CAPA for timely and effective closure
- Manage change control and assess quality risks from process or system changes
- Review and approve SOPs, BMRs, validation documents, protocols, and reports
- Review and approve GMP documentation, validation protocols, qualification reports, and quality records
Key requirements
- GMP compliance and regulatory inspections and customer audits
- Quality Management Systems (QMS), CAPA, and root cause analysis
- Internal quality auditing and quality risk management
- Change control, process validation, equipment qualification, and cleaning validation
- Computerized system validation and quality documentation review and approval
- Quality metrics and reporting, plus customer complaint and non-conformance management
- Pharmacy / Chemistry / Biology / Chemical Engineering
Benefits
- Plenty of chances to grow personally and professionally in an open, dynamic environment where ideas and talents can shine.
- Fagron is an equal opportunity employer committed to an inclusive workplace.
About the job
About the job - Lead and mentor the Quality team to achieve quality objectives - Maintain and continuously improve Quality Management System (QMS) - Develop, implement, and maintain quality management systems, processes, and procedures - Monitor product or service quality throughout the production…
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.