Industrial Pharmacist QA

Contenuto del lavoro

New opportunity as Industrial Pharmacist at BAXTER Lessines, pharmaceutical leader .

The Industrial Pharmacist QA has as main objectives:

Actively involved in cluster projects and QA improvement initiatives.

Ensure appropriate contacts with the country Regulatory Affairs (RA), Vigilance, Warehouse & Distribution (W&D), QA Manufacturing and Businesses are maintained.

Ensure that processes and procedures related to mentioned activities are compliant to legislation, to the Corporate Quality Manual and to the ISO 9001/13485 requirements

Its main responsibilities are:

• Being the Qualified Person (QP) of BDCE.
• Being the contact with authorities ( Ministry of Health) for all quality related aspects.
• Management and supervision of batch records and relabeling files, as well as quality systems for all relabeling works (change control, NCR).
• Being the QA contact person for the Raw Material warehouse and 3rd party suppliers (warehousing, relabeling) used by BDCE
• Management and monitoring for all NCR, CAPA and Complaints.
• Provide support for hold corporate products
• Being the QA reviewer, approver and the legal representative for BDCE SCARs Audits and Inspections (annual Internal Audit program, Supplier Audit program, External Audits)
• Providing support for validation
• Leading GMP related projects

PROFILE :

• Master’s degree in Pharmaceutical Sciences WITH Advanced Master’s in industrial pharmacy
• Certified QP from Belgian FAMHP
• Very good knowledge of Good Distribution Practices (GDP), Good Manufacturing Practices (GMP)
• Excellent knowledge of applicable Legislation, Eudralex, cGMP, cGDP and Quality Systems
• Fluent in English and French
• Good computer skills (Outlook, Windows, ERP, Word, Excel, etc); knowledge of JDE, WMS, TW8 is an asset.
• Strong communication skills: interact efficiently with all levels of local and international organization.
• Team spirit minded

OFFER

We propose a CDI contract / permanent contract in one of the largest and leading companies in the Pharmaceutical Sector located in Lessines : BAXTER for his European Distribution Center

Here, the benefits to work for the company BAXTER as Industrial Pharmacist :

• Attractive salary
• Lunch voucher
• Refund in the travel expenses (go & return)
• Insurances
• Etc

Interested by this challenge ? Send quickly your application !