For a flexible and dynamic pharmaceutical SME which aims to place value-added and quality products on the market, Real Staffing is currently looking for a QA Manager / QP. This company markets a range of medicinal products, medical devices, food supplements and cosmetics, covering different therapeutic areas. They intend to further their growth by new products launches and an increased presence on the international level.
The job is focused on medicinal products, and to a lesser extent on food supplements and cosmetics.
Your responsabilities will be the following:
- Responsible Person for GDP Deputy (RP deputy) - Benelux
- Qualified Person for GMP Deputy (QP deputy) - Belgium only
Assure the operational tasks linked to the responsibilities of RP deputy - Benelux:
- ensuring that a quality management system is implemented and maintained;
- focusing on the management of authorized activities and the accuracy and quality of records;
- coordinating and promptly performing any recall operations for medicinal products;
- ensuring that relevant customer complaints are dealt with effectively;
- ensuring that CAPAs and deviations are timely and efficiently dealt with;
- ensuring that Change Controls are dealt with efficiently;
- ensuring that suppliers and customers are approved;
- approving any subcontracted activities which may impact on GDP;
- ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place;
- ensuring internal/external audit management
- approving incoming medicinal products to saleable stock
- deciding on the final disposition of returned, rejected, recalled or falsified products;
- approving any returns to saleable stock;
- ensuring that any additional requirements imposed on psychotropics by national law are adhered to.
Assure the operational tasks linked to the responsibilities of QP deputy - Belgium only:
- ensuring that repacking activities (limited to medical samples, secondary packaging and leaflets) are compliant;
- ensuring batch certification for the products for which Will Pharma is batch releaser.
- Industrial Pharmacist
- 5-8 years experience in GDP and GMP
- Thorough knowledge of GDP
- Good knowledge of GMP
- IT: standard use of Microsoft Office applications
- Fluent in French, English. Dutch is a big plus.
- Strong written and verbal communication, interpersonal and customer-service skills.
- Strong organizational, project management, time management, problem-solving skills and the ability to work accurately and meet deadlines.
- Ability to work well independently, as well as part of a team.
- Ability to exercise proactivity, flexibility, initiative, good judgment and discretion.
This is the perfect opportunity to increase your responsabilities and to act as a QP.
We want to hire a professional person who will be able to grow with the company and the package offered reflects this intention: Interesting salary, company car, advantages, …
Should you be interested to know more about this opportunity, please apply today or contact Isabelle Leparlier on 02.610.59.15 for more information.