9 CAPA Jobs in the South East

candidate will carry out evaluations of data integrity documentation periodically and as needed. Offer aid for any other quality systems which involves Non-Conformances, CAPA, QTAs, as applicable connected to GxP IT systems. Collaborate with IT associates assuring suitable oversight of IT systems. Mediate with IT division associates linked to more »

and Pharmacovigilance · Experience in Monitoring, Quality Assurance and/or Good Clinical Practices · Exposure to inspections COMPETENCIES · Understanding of pharmacovigilance · Understanding of audits and CAPA management · Understanding of change management processes · Well versed with MS Office (advance users in Excel & PowerPoint preferred) · Excellent communication skills (written and oral) in English more »

model are documented accordingly in TMF Plan or other applicable document. Document and escalate all identified compliance issues. Follow-up findings until resolution/CAPA implementation. Monitor project scope and communicate any identified out-of-scope activity or requests to the Project Lead. Receive sponsor-specific report requests (confirm required more »

corrective actions. 4. Establish and maintain quality policies, procedures, and documentation to support compliance with regulatory requirements. Management of QMS Processes such as NC, CAPA and Change. 5. Collaborate with cross-functional teams to integrate quality considerations into product development processes. 6. Provide training and guidance to employees on quality more »

supplier audits; Support continuous improvement projects; Monitor customer and supplier rejects and highlight trends whilst implementing preventative and corrective actions to prevent reoccurrences; Complete CAPA, 8D or SCAR paperwork for customer returns Issue and update regulatory declarations (REACH, TOHS, TSCA etc); Complete supplier questionnaires for customers; Issue quarterly board updates more »

to address constraints. Lead the execution of common IT processes across Data Platforms solutions and services. (ie. Access Roster Reviews, Periodic Reviews and other CAPA activities.) Represent the team in vendor governance meetings and ensure compliance with change management and ITSM processes. Minimum Qualification (education, experience and/or training more »

Senior GxP IT Compliance Specialist As the Senior GxP IT Compliance Specialist, you will lead compliance efforts for critical systems essential to GxP operations. Your role involves overseeing GxP IT systems from a quality assurance perspective, ensuring adherence to regulations more »

Change Control documentation for Quality Assurance Support the maintenance of Quality System documentation Analyse and communicate proposed, new or changing requirements Review and approve CAPA documentation Provide support to routine manufacturing activities, projects, development and training Experience required: Experience working in Quality Assurance Experience operating in ISO9001 environment Excellent working … knowledge of document management systems, change control and CAPA systems Knowledge and experience of working in an ISO13485 environment is advantageous Good team player and able to work in a fast-paced environment with minimal supervision Keywords: Quality Assurance Specialist, QA Specialist, Regulatory Specialist, Quality Assurance Manager, QA Manager, ISO9001 more »

their Improvement Culture, using your insight and analysis from performing audits as to were improvements can be implemented Play an instrumental part in their CAPA division within their Quality Team, this means that you will take the reigns on investigating non-conformances and collaborate on CAPA objectives. Working with the … client) Hands on knowledge of IS0 3485 i.e. you have worked in medical device manufacturing in a quality engineering role. Solid understanding of running CAPA driven activities, therefore you will be able to provide examples of where you have worked on CAPA driven initiatives within medical device manufacturing. Thank you more »