Pharmaceutical Quality Assurance Specialist
7 days ago
We are seeking an experienced Pharmaceutical Quality Assurance Specialist to join our team at Guy's and St Thomas' NHS Foundation Trust. As a key member of our Quality Assurance department, you will play a vital role in ensuring the highest standards of quality and compliance in our pharmaceutical manufacturing and quality control units.
Key Responsibilities- Quality Management System
- Develop and maintain the integrated Quality Management System across the Pharmacy Manufacturing Service, ensuring compliance with MS, MA(IMP) licences, and NHS guidance.
- Act as a Releasing Officer for unlicensed products received into the Trust, ensuring adherence to regulatory requirements.
- Technical Support and Advice
- Provide technical support and advice on Quality Assurance to other departments within the Trust and external customers.
- Service Evaluation and Development
- Critically assess the current Quality Management System to maintain a continuous quality improvement cycle within the department.
- Update and enhance current unit documentation in line with accepted guidelines and changes in the workings of the QA department.
- Clinical Trials
- Review new trials requiring QA services to ensure compliance with The Medicines for Human Use (Clinical Trial) Regulations 2004.
- Review and authorise all clinical trial production documentation to ensure preparation of clinical trials complies with all regulator requirements.
- Research and Development
- Provide QA support to the development, formulation, and validation of new products in response to clinical need and risk management.
- Qualifications
- Pharmacy degree or Masters degree in a science-based discipline.
- Post-graduate qualification relevant to pharmaceutical manufacturing or a portfolio demonstrating equivalent specialist pharmaceutical knowledge.
- Experience
- Previous evaluated experience working as a Releasing Officer in a licensed/unlicensed pharmaceutical production unit with a comprehensive portfolio of products.
- Experience of quality systems and documentation management systems.
- Skills
- Demonstrated practical knowledge of GMP, QA, risk management, and all current relevant regulations.
- Demonstrated ability to identify and manage risks.
- Demonstrated ability to undertake the day-to-day management, motivation, and appraisal of staff.
As a Pharmaceutical Quality Assurance Specialist at Guy's and St Thomas' NHS Foundation Trust, you will have the opportunity to work in a dynamic and supportive environment, contributing to the delivery of high-quality patient care. We offer a competitive salary and a range of benefits, including opportunities for professional development and career progression.
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