RA & QA Manager Benelux
That's XPE. For one of our clients we are looking for: RA & QA Manager Benelux Organisation description:
Our client, an innovative pharmaceutical group dedicated to medical imaging worldwide and pioneer in contrast media, is hiring a motivated, QA & RA Manager Benelux with a first relevant experience in the pharmaceutical industry, this is a full time permanent contract directly offered by our client.Job description:
You are a member of the Benelux Medical Affairs Department and you're main focus will be on Regulatory affairs and reimbursement & Pharmaceutical and Quality affairs and acting as Responsible Person for Belgium, Luxembourg and the Netherlands.
Regulatory affairs and reimbursement (RA)
You are in charge of the local regulatory intelligence and the contact with the authorities.
Checking the legal and regulatory compliance as well as the scientific content of the documentation sent by the Corporate RA department is as well part of your responsibilities.
Furthermore, you submit variations, renewals and new marketing authorization applications to the competent authority, attach any relevant documentation according to the local requirements and translate some documents to French and Dutch.
Upon the agency's request, you provide answers and additional documentation. You follow-up on pending approvals and inform the Corporate RA department about the status.
Based on your expertise and knowledge of the Belgian, Luxembourgian and Dutch laws you propose a regulatory strategy, you apply for pricing and reimbursement of the products and execute the decisions of the commissions.
You revise and validate the texts of the packaging materials and support the systematic updating of specifications (Change management), of variations, of packaging (a.o.) influencing market release and GMP compliance. In case of SmPC updates, you perform an impact analysis to assess the consequences in terms of product information.
Regarding pharmacovigilance, you are in charge of submitting all issues such as PSURs, new SmPCs and other safety related documents to the competent authority.
Pharmaceutical and Quality affairs
As Responsible Person in Belgium, Luxembourg and the Netherlands, you implement locally the Good Pharmaceutical Practice (GPP) policy of the Benelux Company defining a general pharmaceutical quality policy, strategy and objectives taking in account due diligence and general rules of continuous quality improvement (management review, risk management based principles a.o.).
You ensures that a GDP/GMP/GCP/GVP compliant quality management system is implemented and maintained with clear definition and demarcation of local and global standard operating procedures and instructions.
The preparation and follow-up of inspections and audits, including all subcontractors, suppliers and self-inspections, is your responsibility in close collaboration with the headquarters quality department. As well as the local implementation of the preventive and corrective actions (CAPA).
You establish the procedures for purchasing, reception, storage, control, inventory, invoicing and distribution of the products in the warehouse or with the external distributors and subcontractors.
Next, you authorize the market release or market rejection of product batches, any recall operation for medicinal products and you decide on the final disposition of returned, rejected, recalled or falsified products.
The management of product quality complaints and validation of the periodic quality reports (PQR) fall as well under your tasks.
Finally, you ensure that initial and continuous training programs are implemented and that written job descriptions are prepared and updated for all staff members involved in pharmaceutical and pharmacovigilance activities.
In order to accomplish the responsibility of Responsible Person, you have free access to all areas, sites, files, data, records related to the activities being performed.Profile:
The ideal candidate is a pharmacist or scientist with sufficient and legal qualifications and at least a first experience to locally manage RA and QA activities. This includes general GMP, Regulatory and Quality expertise, to act as Responsible Person.
Dutch, French, and English hold no secrets from you and you can effectively and fluently communicate in all 3 languages.Offer:
You are offered a permanent, full time contract on the client's payroll and a competitive salary including an extra-legal package.
Last but not least, you gain experience in an innovative, international, challenging and rewarding working environment.
XPE Personnel Services NV/SA: Flanders: VG15/BU, Brussels: B-AA5.031, Wallonia: W.RS.002/W.INT.002 XPE Group NV/SA : Flanders: VG1834/B, Brussels: B-AA11.007, Wallonia: W.RS.713