Quality Assurance Specialist - Genesis Pharmaceuticals Ltd. / Genethics Regulatory Services Ltd. - 84 Pembroke Road, London W8 6NX
(2024-12)
- QA Batch review evaluation of manufacturing & QC data and resolving issues with CMO
- Raising of QA Batch release and QP Batch Certification
- Preparation of Certificate of conformity and Summary of Batches Released for the QP
- Co-ordination of weekly QA Batch review
- Artworks confirmation (Blister/Pot Foil, Blister/Pot Carton and PIL) for the monthly Purchase Order
- Artworks re-confirmation to CMO at time of manufacturing
- Review and approval of Change request from CMO
- Raising Change control, Review and follow up to closure
- Ensure manufacturing site, API manufacturing site, excipients and packaging materials are all MAH compliant
- Review and approval of the Batch Manufacturing Records and Batch packaging Records for the CMO
- Logging and filling of Master Documents
- Support investigations into customer complaints and CAPAs
- Update, Review and approval of SOP
- Maintaining the Quality logs such as CC, Dev, Master documents, Artwork, CAPA
- Provide ongoing QA support to ensure full compliance with regulatory and internal quality standards
- Organising and participating in quality training sessions such as refresher GMP, Data Integrity & SOP trainings
- Review of Temperature logger data and identify non-compliances
- Review of transportation documents to ensure compliance
- QA Sample checks of finished products
- Review of Analytical test results and Identify OOS, gaps in the CMO and UK results
- Support MHRA Inspection, responses and CAPA
Quality Assurance Specialist - Torchlight Genetic Limited - Morelands & Riverdale buildings, lower Sunbury rd., Hampton TW12 2ER
(2023-10 - 2024-09)
- Support the manufacturing of ATMPs, review and approval of the associated documents
- Ensuring compliance with the relevant regulatory requirements (GMP, GDP)
- Maintaining Quality standards during development, manufacturing, testing, and shipping of the ATPS
- Management of the QMS records and ensuring completion in timely manner
- Identifying opportunities for improvement, implementing those continuous improvement initiatives
- Partner with cross-functional team to drive CI across QA and multifunctional team and uphold product integrity
- Supporting Internal, Client, Supplier and Regulatory Audits
- Review and approval of Batch manufacturing records before QP release
- Support Customer complaints and product recall
- Review and approval of Environmental monitoring documents
- Support material and vendor assessment & approval processes
- Review and approval of QCTMs, Reagent sheets
- SAP transactions - process inspection lots, Post goods movement, release, Blocking and unblocking of materials
- Organise and participate in quality training sessions
- Support supply chain assessment, excipient risk assessment and TSE/BSE free statements
- Review and approval of Testo data (Monthly Temperature logger data)
- Support in compilation of the PQR
- Participate in risk assessment and risk mitigation strategies
- A holistic approach to quality risk management, root cause analysis and FMEA processes and how this is applied throughout the lifecycle of a product
- Working closely with colleagues in the compliance, validation, regulatory, operations and developments
- Oversee day to day document control - Doc issue, return, reconciliation, and achieving-paper based & electronically
- Maintain and control document release to GxP in timely manner – SOP, BMR, QCA-etc
- Ensuring accuracy, completeness, and compliance of all GxP documents filed, stored and achieved (electronically and Paper based)
- Print and apply QA Labels to finished products and facilitate task are completed contemporaneously
Quality Assurance Specialist - ThermoFisher Scientific - Brook Drive, Milton Park, Abingdon, OX14 4SD
(2022-12 - 2023-08)
- Review and closure of batch manufacturing records and resolving any issue with production Dept
- Provide QA oversight to ope
