Quality Assurance Specialist
Location Home Counties, Oxon/Wilts, South West England
Salary Up to £35,000
We have an exciting new opening for a Quality Assurance Specialist at a leading Pharmaceutical CMO company in Oxfordshire. The main responsibility will ensure compliance to cGMP, company policy and best practice, and support manufacture of developmental and commercial APIs at various scales.
Key Responsibilities and Duties:
- Provide Quality support, coaching and guidance across all departments, as well as technical GMP support to Analytical and Production departments and Clients
- Conduct internal and external audits of sub-contractors and suppliers; occasional travel within UK and overseas will be required
- Train junior members and site personnel and conduct GMP compliance projects across the site
- Investigate root cause analysis, identify inefficient processes, introduce lean alternatives and drive effective CAPA
- Practice continuous quality and process improvement in QA
- Mange method and equipment validation, deviations and calibration
- Arrange and participate in project management meetings and activities
- Admin-related work on GMP systems and processes, and generating Quality Assurance documentation
Ideal Skills and Qualifications:
- Degree-qualified, or equivalent, in Chemistry or a similar scientific discipline
- Minimum 3 years’ experience and technical competence in Quality Assurance
- Previous experience of compliance management including working to cGMP or ICH Q7
- Exposure to a manufacturing environment with strong knowledge of APIs and analysis of drug substance or drug products
- Excellent communication, time management and organisational skills
- Proactive in Root Cause Analysis, implementing solutions and supporting a “right first time” culture
You will be working for a diverse global company with state-of-the-art facilities, who values and builds on trust, quality and teamwork. You will receive a highly competitive salary with excellent company benefits.
If you are interested or have any questions about this role, feel free to contact Harriet at CY Partners.