Vos responsabilités
Qualified Person
You would like to pursue your career in the pharmaceuticals sector? You enjoy working on challenging projects? You're versatile, organized and dedicated? Taking responsibilities doesn't scare you?
So, you are the next Qualified Person of our client!
Organization
Our client is a key pharma partner dedicated to the success of several multinational pharmaceutical companies.
Responsibilities
Batch Review and Release
- Manage the system of batch review and release
- Release products according to the procedure (QP confirmation and certification)
- Review and approve the deviation reports and incoming complaints
- Verify the documents of conformity and the packaging of commercial products according to the procedure
- Verify the additional labeling according to the procedures for clinical trial supply
- Ensure the GMP certification of secondary packaging performed according to the current procedures
- In charge of the approval of master labels
GxP Authorization & Regulatory
- Ensure that the activities realized within the company enter within the scope of the current authorization 860 (H and IMP)
- Maintain the regulatory authorizations of the site updated according to the activities performed
- Ensure a regulatory monitoring of GMP and GDP standards and regulations
- Primary point of contact with Belgium authorities.
Product Quality Review
- Manage the Product Quality Review's system
- Perform the Product Quality Review Report writing and analyze/discuss trends.
Recall and Return Processes
- Manage the recall procedure
- Responsible to launch and manage product recall process
- Approve the product's returns
External Quality
- Manage the quality agreement procedure
- Review and Approve the quality contracts with the customers and the suppliers (Quality Agreement)
- Approve GxP suppliers
As Qualified Person you report directly to the Head of Quality Unit.
Key-words: GDP, GMP, QP, Pharmaceuticals, Pharmacy, FAMHP, Procedure, Product Quality Review, Management, GxP, Medicinal Products
Votre profil
In this role of QP, you will make sure our client is adhering strictly to the Guidelines on Good Distribution Practice and Good Manufacturing Practice of Medicinal Products. Also, you will apply the requirements of the customers and the quality policy of the company regarding the operations of secondary packaging, release, storage and distribution of medicinal products
Your profile
- You have a master's degree in industrial pharmacy and you have been certified by FAMHP as a Qualified Person.
- An experience of 5-10 years in the pharmaceutical manufacturing and/or distribution sector of pharmaceutical products should be an asset.
- Your organization skills, your flexibility and your drive allow you to lead and achieve several projects at the same time.
- You have high analytical capabilities, which allow you to solve customer-oriented problems and to contribute to the continuous improvements of our processes.
- You are stress resistant, proactive, pragmatic and risk-based approach oriented.
- In addition, you have a very good knowledge of IT tools and are fluent in English and French (Dutch is a plus).
Notre offre
Our offer
Our client offers you a full-time job with a long-term contract, in a dynamic and ambitious environment with possibility to develop your skills and a salary package matching your competence.
Interested? We invite you to apply directly on our website (experis.be). For more information, contact Marie Defruit via
