Nikunj Patel

Senior Quality Assurance Officer @Noumed Life Sciences Limited

Maidenhead, GB

Support QMS Creation and Maintenance: Played a key role in the creation, maintenance, and continuous improvement of Achilles Quality Management System, ensuring compliance with all relevant regulatory requirements- Document Management System Administration: Supported the administration of the company\'s document management system, ensuring all documents are up-to-date and compliant- GMP Documentation Review: Performed QA review and approval of procedures, master batch records, and other relevant cGMP documentation, maintaining high standards of quality and compliance- Batch Documentation Review: Executed batch documentation review activities, ensuring accuracy and adherence to SOPs- SOP Compliance Review: Reviewed standard operating procedures to ensure compliance with GMP and other regulatory requirements- Change Controls: Managed the review and approval of change controls to ensure compliance and quality- Deviation Investigations: Supported operational functions with the review and approval of deviation investigations, ensuring effective root cause analysis- Timely Documentation Approval: Ensured deviations, CAPAs, protocols/reports, and other applicable documents were approved within designated timelines- Quality Issue Investigations: Collaborated with teams to investigate quality issues and implement corrective actions- CAPA Management: Issued and reviewed corrective and preventative actions (CA/PAs), ensuring effective implementation- Complaints Management: Supported the complaints management process and responded to complaint investigations as necessary- QA Guidance: Provided advice and guidance to the wider team with support from the QA Manager- Internal and External Audits: Performed internal audits to determine GMP compliance and identify areas for improvement; conducted external audits as necessary- Training: Supported the provision of in-house training activities to enhance team knowledge and compliance.