For a customer in Limburg, we are searching for QA Specialist with a scientific profile who can apply all elements of the Quality Management System (QMS) support the Lead Qualified Person (QP) in ensuring that every batch is manufactured and tested in compliance with applicable legislation and Marketing Authorization requirements.
This is a part-time role for 2 days per week. Freelance or Employment Consultancy is considered.
Key Responsibilities
- Contribute to the continuous improvement of the Quality System to maintain the appropriate cGMP standards for processes and systems.
- Participate in cGMP improvement initiatives.
- Support the monitoring and effectiveness of the Quality Management System by overseeing change requests, customer complaints, deviations, incidents, and CAPA plans.
- Provide guidance on internal deviation handling and CAPA implementation.
- Review and approve final investigation reports related to incidents and customer complaints.
- Ensure the integrity of batch documentation through batch record review, analytical record review, and verification of other relevant batch documentation.
- Prepare and finalize Annual Product Reviews (APR) / Product Quality Reviews (PQR) in a timely manner.
- Participate in cross-functional projects, contributing to:
- Project execution
- Validation strategy and activities
- Compliance with regulatory requirements and customer expectations
- Successful implementation into the production environment
- Review validation documentation as part of project activities.
- Report project progress and validation activities during weekly meetings with delegated Qualified Persons and the Lead QP.
- Perform and/or support structured problem-solving activities by evaluating situations, identifying potential solutions, selecting the most appropriate course of action, and approving action plans.
- Deliver training to colleagues through coaching, demonstrations, group sessions, and practical instruction.
- Play a key supporting role during customer audits and regulatory inspections.
Profile
- A Master’s degree, Industrial Pharmacist qualification, or equivalent (e.g., Biomedical Sciences or Bioengineering).
- Relevant experience and training within pharmaceutical manufacturing.
- Experience with (secondary) pharmaceutical packaging processes is considered an advantage.
- 3–5 years of solid experience as a Quality Assurance Specialist within the pharmaceutical or food manufacturing industry.
- Good working knowledge of international cGMP guidelines and pharmaceutical regulations.
- Knowledge of other quality management systems (HACCP, food regulations, or medical device regulations) is an asset.
- Strong sense of ownership
- Team player who can collaborate effectively across all organizational levels
- High level of integrity
- Positive, solution-oriented mindset
- Decisive
- Detail-oriented
- Well-organized with strong prioritization skills
Additional Details
SENIORITY: Senior
START DATE: September
DURATION: 12 Months+
EXTENSION: Yes
CONTRACT: Freelance
LOCATION: Limburg
ONSITE POLICY: 2 days per week
HOURS PER WEEK: 16
LANGUAGES: Fluent Dutch
INTERVIEW PROCESS: 2 Stages