Quality Assurance Specialist - UK
A major biotechnology company, with an extensive pipeline and commercial portfolio in oncology and immunology, currently has an exciting new job opportunity for a Quality Assurance Specialist to join their UK team. This is an excellent opportunity to join an innovative company that delivers life-changing drugs with over 4,000 employees in over 50 countries worldwide.
- Supporting and executing routine quality assurance tasks to ensure compliance with all GMP, regulatory and corporate requirements. Products may be for investigational or commercial use.
- Managing contractor quality compliance activities to ensure product is manufactured, packaged, tested, released and distributed in compliance with all regulatory and corporate requirements. This includes:
- Building and maintaining good working relationships with the contractor.
- Leading discussions with the contractor on quality related topics, such as complaints, change control, deviations, OOS records, processes, methods, procedures, documentation, etc.
- Recommending quality related improvements to the contractor
- Overseeing completion of contractor quality related activities, such as process, method and procedural improvements, quality investigations, corrective and preventive actions, etc.
- Review batch records, both master production/packaging records and executed batch records ensuring compliance with GMP and registration requirements.
- Managing change control requests. This includes, as necessary, initiating and approval routing of change control requests.
- Performing QA evaluation and endorsement/approval.
- Reviewing of associated contractor change control requests.
- Monitoring progress of related action items.
- Processing product complaints. This includes, as necessary, recording complaint details and contacting complainant for additional information and/or to request samples.
- Contacting CSP to coordinate manufacturing investigation.
- Finalising complaint investigation.
- Performing and monitoring trend analyses and reporting to upper management.
- Reviewing, editing, negotiating improvements to, and approve CSP documentation, including process validation protocols and reports.
- Transfer validation protocol and reports investigations, deviations, OOS records Author Product Quality Review reports, as necessary. Or, review, edit, negotiate improvements to contractor supplied Product Quality Review reports.
- Drafting or reviewing, negotiating with contractors, and recommending approval for Quality Agreements Participate in self inspections as appropriate participate in external audits of contractor manufacturers and distributors as assigned.
- Ensuring logs, databases and files related to the product quality activities are maintained.
- Performance of trend reviews and compilation of metrics for non-product related duties
- Developing and/or maintaining pharmaceutical quality systems.
- Author and/or revise standard operating procedures and associated work instructions.
- Review and provide recommendations on policies and standards.
- Support GMP/GDP site inspections.
- Maintain compliance with personal training requirements.
Skills and Requirements:
- BSc/ Bachelor of Science CSP.
- Contract Service Provider GDP.
- Good Distribution Practices GMP.
- Good Manufacturing Practices OOS.
- Out of Specification QA.
- Quality Assurance SOP.
- Standard Operating Procedure.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Steve Fuller at +44 203 854 2630 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.