Responsibilities:
1. Batch Record Review
2. Release Preparation
- Support the release preparation activities, in order to generate a complete batch dossier package
3. Deviation Management
- Review, assess, and close minor deviations.
- Perform basic Root Cause Analysis (RCA).
- Escalate major and critical deviations to senior QA or management.
4. CAPA Execution & Follow-Up
- Initiate and execute CAPAs.
- Track and ensure timely completion of CAPA actions.
- Verify CAPA effectiveness and document findings.
5. Quality Investigations & Compliance
- Support investigations for minor product complaints and minor process deviations and events.
- Ensure proper documentation and compliance with GMP regulations.
6. Change Control Support
- Support minor Change Controls related to deviations and CAPAs.
- Ensure proper documentation of Change Control impact.
7. Audit & Inspection Support
- Provide input for audits and inspections regarding deviations and CAPAs.
- Support preparation of CAPA-related audit responses.
- QA shopfloor activities
8. Process Improvement
- Suggest improvements in CAPA and deviation handling processes.
- Review and approval of procedures and work instructions
- Contribute to continuous improvement initiatives.
GxP
Takes GxP requirements into account during preparation, execution and reporting of GxP activities. Is fully aware of key SOPs such as procedures for Events, OOS and good documentation practice. Follows mandatory GxP training and maintains an appropriate training record. Identifies and escalates GxP issues.
Your Profile:
- Bachelor/ Academic (Master’s degree) in Life Sciences/ Pharmacy.
- Bachelor > 2 years experience or young Academic (MSc).
- Basic knowledge of the GMP-guidelines and experience with biological intermediates, drug substances and aseptic manufacturing preferred.
- Experience with Trackwise/ Mastercontrol/ SAP or similar.
- Dutch and English speaking (work proficiency), English writing skills.
- You naturally take a proactive approach are an analytical thinker and clear communicator.
- Ability to work fully on-site.
What we offer:
- Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed.
- Salary between € 4.179,77 and € 6.008,42 gross per month (based on full-time employment).
- 8.33% holiday allowance and a 13th month.
- 30 holiday days (based on fte).
- A personal training budget of €2,100 every three years to foster professional growth and development.
- Contribution to travel expenses from the first kilometer.
- Excellent accessibility by public transport and private parking available.
- A pension plan with Zorg & Welzijn, providing security for your future.
