Senior Part-Time QA Specialist – Pharma/cGMP

Vivid Resourcing; Limburg; Sur place; EUR 32 000 - 52 000; Temps partiel

Résumé du poste

Vivid Resourcing seeks a Senior QA Specialist with a strong pharmaceutical QA background for Limburg. This part-time role requires 16 hours per week, with freelance engagement and a start in September.

You will support QMS, ensure compliance with cGMP, and assist the Lead QP to guarantee batch quality across manufacturing and testing. The candidate should have 3–5 years in QA within pharma/food manufacturing, a Master’s or equivalent, and Dutch language proficiency.

Qualifications

• Master's degree or equivalent in pharma/biomedical sciences or related field.
• Relevant experience in pharmaceutical manufacturing and QA roles.
• Experience with secondary packaging is an advantage.

Responsabilités

• Contribute to QMS and maintain cGMP standards.
• Support CAPA, deviations, incidents, and change requests.
• Review investigations and batch documentation for quality compliance.
• Prepare Annual Product Reviews and Product Quality Reports.
• Collaborate across teams and participate in audits/regulatory inspections.
• Deliver training and coach colleagues on quality processes.

Connaissances

Quality Assurance

cGMP knowledge

Pharma manufacturing

Problem-solving

Audits

Cross-functional collaboration

Formation

Master's degree or equivalent in pharma/biomedical sciences

Description du poste

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.

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

SENIORITY: Senior

START DATE: September

DURATION: EOY

EXTENSION: Yes

CONTRACT: Freelance

LOCATION: Limburg

HOURS PER WEEK: Flexible (part-time or full-time)

LANGUAGES: Fluent Dutch

INTERVIEW PROCESS: 2 Stages

If you are interested, please forward your updated resume to [e-mail] to be considered.