To reinforce the Quality department, infarAMA is currently looking for a
Quality Assurance Officer or Junior QA Officer
About infarAMA
infarAMA is an independent consultancy company providing high standard professional expertise in global regulatory affairs, quality assurance, vigilance and translation services to the health care industry within Benelux. infarAMA is headquartered in Strombeek-Bever and has a brand-new subsidiary in Aarschot.
Key responsibilities
- Support the Quality Assurance (QA) department
- Prepare the administrative release of finished products (medicinal products/medical devices)
- Follow-up on the implementation of new artwork
- Evaluate the destination of returned products
- Handle product complaints and deviations
- Assist in activities related to final product release by the QP (review batch documentation)
- Write and implement standard operating procedures according to customer specifications
- Ensure compliance with all applicable GDP/GMP regulations
- Prepare and provide adequate training regarding QA procedures to staff and contractors
- Participate in self-inspections and audits
- Prepare quality variation dossiers in cooperation with the Regulatory Affairs department
- Manage the QA documentation
Required profile
- Scientific degree or relevant experience (Min. 2 years in a QA department – irrelevant for Junior Officer positions)
- Fluent in English, Dutch and French with excellent oral and written communication skills
- Strong knowledge of current software
- Enthusiastic, meticulous, methodological, flexible and reliable
- Able to work both independently and in teams
Offer
- A varied job consisting in challenging multi-disciplinary tasks in a dynamic and growing environment
- Competitive benefits and compensation packages
- Workplace in Aarschot or in Strombeek-Bever
Applications
Interested? Send your resume and application letter to p.vandenweghe@infarama.be.
For more information, feel free to contact us.