Sr. QA Manager
Sr. QA Manager
Ou client develops and distributes active pharmaceutical ingredients for humans and animals. These active substances are distributed to pharmaceutical manufacturers worldwide.
QA is responsible for setting up, maintaining and optimizing the quality system and the quality level of processes, products and services of the company in general.
- Responsible for the release of production batches;
- Responsible for manufacturing, acquiring and maintaining permits
- Managing and keeping the quality and documentation system up to date;
- Carrying out activities for the purpose of obtaining and retaining certifications and recognitions;
- Managing and coaching the QA / RA team
- Monitoring crucial processes such as complaints, deviations, CAPAs, etc.
- Drafting, implementing and reporting KPIs
- Direct contact for (GMP / FDA) inspections and audits
- Focus on innovations and development opportunities in the QA / RA area, digitization and the application thereof
- Analyzing findings and trends and then converting them into concrete follow-up and improvement points
- WO education in (bio) chemistry, pharmacy, life sciences
- Minimum 5 years experience as a QA manager
- At least 10 years of demonstrable work experience in a GMP environment; experience with FDA is an advantage;
- Experience in performing and working with risk assessments, root cause analyzes, KPIs;
- Excellent in Dutch and English.
If you are interested in this role, please contact me at email@example.com or at +31 20 658 98 00.