Location: Brussels, Belgium
Quality Assurance/ Responsible Person:
Act as Responsible Person of our client (Pharma Company) in line with Art. 90 and 95§2 of the Royal Decree of 14 December 2006 regarding medicines for human and veterinary use and with GDP guidelines. The responsibilities of the Responsible Person include:
- Ensuring that a quality management system is implemented and maintained
- Focusing on the management of authorized activities and the accuracy and quality of records
- Ensuring that initial and continuous training programes are implemented and maintained
- Coordinating and promptly performing any recall operations for medicinal products Ensuring that relevant customer complaints are dealt with effectively
- 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 programe and necessary corrective measures are put in place
- Keeping appropriate records of any delegated duties
- 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 certain products by national law are adhered to
- Perform administrative controls of products entering the market Management of nearly expired goods
- Maintenance overall distribution licenses for Medicinal Products, Narcotic and Psychotropic Products, Food Supplements and Medical Devices
- Give support to EQM to ensure that Technical Agreements with third parties are in place for all marketed products
- Preparation of audits and inspections and the execution of related CAPA plans
Job Requirements:
- Educational background: (Industrial) pharmacist
- Authorization as qualified person for Pharmaceutical Information Experience: 1-2 years in QA environment
- Languages: Dutch, French and English
- IT: Outlook, Word, powerpoint, Excel
- (Inter)personal skills’ Highly motivated and organized person with a flexible attitude; detail oriented, autonomous, team player, communicative, commercially oriented
