In Bladel, Noord-Brabant, you will lead the QA team and maintain and improve quality systems in pharmaceutical manufacturing. You will oversee GMP compliance, audits and inspections, and drive continuous improvement.
The role
As Quality Assurance Manager at the client company in Bladel, you will maintain and improve quality systems for pharmaceutical manufacturing. You will oversee compliance with quality requirements and GMP and maintain a strong presence in the manufacturing and packaging areas.
Working across functions, you will promote a strong quality culture and continuous process improvement.
Responsibilities
- Support and follow up on CAPAs, deviations, audits and supplier quality management programs.
- Develop and manage the QA team, coaching and mentoring team members on quality management systems and audit practices.
- Participate in internal and external audits and supplier quality activities; support inspections by regulators such as IGJ, FDA and EMA.
- Conduct compliance risk assessments and trend analyses, and recommend compliant ways of working.
- Manage, track and present quality metrics for management reviews, including change controls (CCs), CAPAs, deviations, complaints, PQRs, audits and audit reports.
- Write, review and/or authorize SOPs and other procedures and policies, updating them as needed.
- Train and coach QA team members in conducting audits and documenting findings, and in supporting action plans and effectiveness checks.
- Plan annual internal audits and other required audits; ensure audit-related CAPAs are assigned owners and closed out on time.
- Provide guidance on change management decisions and deviation investigations, monitor QA resource needs, and advise management on standards that improve quality, efficiency and compliance. Report trends, serious quality issues and non-compliances identified during GMP and GDP activities.
What you bring
- 3 to 5 years of experience in the pharmaceutical industry, including management experience.
- Extensive experience in GMP manufacturing and compliance, with knowledge of audit and inspection techniques, including process, system and documentation audits, and quality assurance principles for pharmaceutical manufacturing.
- Competence in managing and tracking quality metrics such as change controls (CCs), CAPAs, deviations, complaints, PQRs, audits and audit reports.
- People leadership experience is preferred.
- Experience working with IGJ and FDA and participating in regulatory inspections.
- Experience in project, time and people management.
Working conditions
The schedule, contract type, working hours and salary are not specified in the available vacancy information.