Senior QA Officer
£30,000 - £35,000 depending on experience
Global Contract testing company
Based in Greater Manchester - commutable from Warrington, Altrincham, Knutsford, Stockport, Manchester
2 roles available
A truly Global company that provides services to the Pharmaceutical industry is looking to appoint 2 experienced Senior QA Officers to their state of the art facility in Greater Manchester.
The successful candidates will be responsible for overall quality performance including the maintenance of the quality management system (QMS), maintaining and developing relationships across teams and enabling continuous improvement of processes. The successful candidate will have a sound working knowledge of GLP, GMP and ISO 9001 / 17025 / 10993.
The successful candidates will also be senior members of the Quality Assurance team and will promote regulatory compliance and ensure quality requirements are met at all times whilst ensuring that company quality policies, processes and procedures are effectively implemented. In addition, the successful candidates will contribute to implementation of a culture of quality assurance and quality improvement, working closely with your operational colleagues and the wider company quality community.
- Management of the Quality Management System (QMS).
- Generation, Review and approval of relevant GMP documentation.
- Help create QA Processes, Standard Operating Procedures, Policies and Training material.
- Maintenance of QA KPI metrics.
- Provide mentorship and development to the QA team members to ensure effective administration of the QMS and document management systems.
- Provide guidance to the QA team members to ensure timely completion of QA team activities.
- Collaborate with Operational areas, proactively manage the day to day QA operations.
- Ensuring timely and adequate release of GMP compliant analysis and reporting in accordance with Regulatory and site-specific authorisations
Qualifications and Experience:
- BSc in a Life Sciences discipline e.g., Chemistry, Biology, Biotechnology, Microbiology etc.
- Direct quality assurance experience, preferably in a fast-paced analytical laboratory or similar environment. Ideally with direct experience in setting up/maintaining a cGMP Quality System.
- Awareness of ISO, GLP, ICH GMP guidelines, FDA/ MHRA regulations
- Experience of working in an GLP regulated (i.e. as a member of a GLP Monitoring Authority programme) environment is preferable
- GMP experience would be desirable