Our client, an international company operating within the pharmaceutical industry, is currently looking for an RP/QA Pharmacist. You will perform duties of the Responsible Person in compliance to Directive 2001/83/EC and S.L. 458 and the Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01).
Responsibilities:
- Ensures that a QMS is implemented and maintained.
- Ensures that any additional requirements imposed on certain products by national law are adhered to.
- Supports the QMS Manager, as required, in the generation, review or approval of Standard Operating Procedures, Polices and other defined critical documentation.
- Support the QMS Manager, as required, in the investigation of deviations and customer complaints, andsupport execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained.
- Ensures that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place.
- Participate in internal GDP training sessions and training requirements within the Quality Unit, as well as coaching of prospective RP personnel.
- Contribute to the continuous development and improvement of Quality systems, processes and procedures.
- Initiating and co-ordinating batch/ product recalls together with the QMS Manager.
- Decides on the final disposition of returned, rejected, recalled or falsified products, and approving any returns to saleable stock.
- Ensures that suppliers and customers are approved.
- Approval of subcontracted activities which may impact on GDP through the respective agreements.
Requirements:
- A recognized qualification (Bachelors Degree or better) in Pharmacy
- Must hold a local pharmacist warrant
- Preferably with 3-4 years experience in an EUGMP/EU GDP Quality Assurance Environment
- Professional level of English and preferably fluent in Maltese
- An understanding of GMP Standards and Regulations
- Reliable, mature and responsible
An attractive remuneration package will be given to the right candidate depending on experience
Job Reference: KO171
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