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EMEA Q&C Lead
Requisition ID: 1805645352W
- To manage the assigned EM(s) portfolio against the acceptable GMP and applicable ISO Standards (i.e: 9001; 13485)
- To participate to due diligences and to carry out GMP/for cause audits and technical support
- Follow-up audit action plan proposal and progress
- To develop and carry out the approval process of the new EM according to the current GMP, ISO and J&J requirements
- Laboratory qualification
- To manage quality issues: review of deviations, out of specifications, non-conformances and other critical issues; investigation review, follow up on resulting action plans
- To assure continuous improvement process of the External Manufacturers through KPI and Management Action Plan and CAPA follow-up
- To collect change control related information from EMs, evaluate proposed changes, collect R&D, regulatory and procurement assessments, prepare action plans and follow up, evaluate product documentation, assess validation protocols and reports
- To review of complaints, support of complaint investigation, follow up of EMs action plan resulting from complaint investigations
- Collect and review of PQRs, follow up on resulting action plan with the assigned EM(s)
- To review of stability data, follow up on action with the assigned EM(s)
- To lead and follow-up on the implementation of the different QA projects/new WWSP (Worldwide Standard Procedures) at the assigned EM sites
- To regularly communicate status & results (including escalation)
- To take part in ERC initiatives at the EMEA regional level within the EMEA regional departments and at the assigned EM(s) sites
- To take part in the implementation of the different QA projects / new J&J standards at a regional and global level
- QA support in Business Continuity Plan (BCP) / Reformulation / CIPs
- Support in supplier reliability initiatives as agreed with line manager and Q&C Projects' leader
- EM business meeting / support to SRM program
- A minimum of a Bachelor's Degree is required in Engineering, Pharmacy, Chemistry, Life Science, or related disciplines.
- 5 -8 years of relevant experience
- Excellent communication skills
- Fluency in English is a must
- Ability to reside in Istanbul
Johnson & Johnson Sihhi Malzeme Ltd. (7347)