Quality System Analyst required for a Maternity Cover contract – pharmaceutical
Operating within the Quality team to ensure commercial products are manufactured and distributed in accordance with all regulatory and corporate requirements.
This role will require a systematic and thorough approach to robust Quality System implementation, and cooperation with all functional teams in order to support the maintenance of an effective Quality System.
- Coordination and Management of Quality System Records relating to Document Control, Training, Deviations, Non-Conforming Material Reports (NCMRs), Corrective & Preventive Action (CAPA), Internal Audit, etc.
- Management of Quality System Metrics to support Corporate QHS initiatives.
- Participate and lead, where relevant, the on-going development of both Corporate and site-level Quality Systems.
- Lead or participate in Internal Audits to assess compliance to the Regulatory and Quality Management System procedure requirements.
- Provide timely issuance of Internal Audit reports and/ or CAPAs.
- Provide timely follow-up on Audit responses and Corrective Actions, and track the completion of activities from scheduling through to audit closure.
- Devise or revise Standard Operating Procedures relating to various quality system elements.
- Provide Quality System support to Manufacturing, Engineering, Supply Chain, Human Resources and Warehouse.
- Provide support for Root Cause Investigations, relating to NCMR and CAPA proposals and initiatives.
- Be the Subject Matter Expert for the Quality department on software integrations that affect the Quality System, such as SAP, Trackwise, etc.
Key Requirements needed
- Bachelor’s Degree in Science, Engineering (mechanical, industrial, chemical, electrical) or equivalent discipline is preferred.
- Minimum 3 years of Medical Device Quality experience in an ISO/ FDA regulated manufacturing environment. Document Control experience is essential.
- 5 or more years of experience preferred.
- Competent using office software including MS Word, Excel, Internet Explorer, Powerpoint and Outlook. Experience working with Compliance Wire is preferred.
- Strong knowledge and understanding of FDA regulations (21CFR 820), ISO13485 and other ISO standards related to medical device manufacturing as required by the position.
Please contact email@example.com for more information