Senior Quality Assurance Officer
The Senior Quality Assurance Officer will be expected to work within the GMP and safety guidelines set by the company. They will assist the Quality Assurance Manager in ensuring the company Quality Management System (QMS) is maintained and complies with the requirements of Good Manufacturing Practice (GMP) as described in the current EU and ICH guidelines.
The duties/responsibilities include but are not limited to the following:
- Perform QA review of batch documentation (batch records, analytical reports/ raw data).
- Perform QA review of final reports
- Perform QA review and approval of GMP stability studies
- Perform the QA review and release of key raw materials and intermediates
- Perform the review and approval of SOP’s and other controlled procedures.
- Review and approve change controls and non-conformances
- Perform internal audits and co-ordinate the timely closure of all audit actions.
- Prepare or support the preparation of and maintenance of technical/quality agreements.
- Assist in the annual GMP training.
- Perform or assist in the training of QA/GMP staff
- Assist in the preparation and dispatch of customer QA package on completion of project.
- Perform general administration duties in the absence of the Document Controller
- Ensure procedures are followed at all times and new issues of Standard Operating Procedures are signed off promptly.
- Demonstrate good safety awareness as described in the Onyx Safety Manual.
- Ensure personal Training Record is signed and updated as applicable and available for review during audits.
- Develop a proactive approach to all aspects of the job, be prepared to take on additional responsibilities as needed.
- Reasonable overtime working as project or management requires.
- Any other reasonable duties required by the Quality Assurance Manager.
Interview expenses from within the UK only.
Applicants must be able to work permanently in the UK.