Our client, a reputable pharmaceutical company, is looking for a Responsible Person - RP. Your responsibilities would include:
- Ensuring that a quality management system is implemented and maintained
- Ensuring that any additional requirements imposed on certain products by national law are adhered to
- Supporting the QA/RA Manager, as required, in the generation, review or approval of Standard Operating Procedures, Polices and other defined critical documentation
- Supporting the QA/RA Manager, as required, in the investigation of deviations and customer complaints, and supporting execution of corrective and preventative actions and related documents to ensure compliance is achieved and maintained
- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
- Participating in internal GDP training sessions and training requirements within the Quality Unit, as well as coaching of prospective RP personnel
- Contributing to the continuous development and improvement of Quality systems, processes and procedures
- Initiating and co-ordinating batch/ product recalls together with the QA/RA Manager
- Deciding on the final disposition of returned, rejected, recalled or falsified products, and approving any returns to saleable stock
- Ensuring that suppliers and customers are approved
- Approving of subcontracted activities which may impact on GDP through the respective agreements
Skill-sets and Requirements
- Previous demonstration of working independently and as part of team with strong collaboration
- Possesses excellent written and spoken communication skills in relevant languages, including English
- Ensures effective delegation whilst retaining ownership of the outcome
Education & Experience
- Qualified to act as Responsible Person (RP)
- Degree in a relevant life sciences subject ideally pharmacy
Job Reference: CO209
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