Senior QA Specialist
This is a brilliant opportunity to join a multinational biopharmaceutical company as a Senior QA Specialist at their base in the UK. This is an organisation that seek to deliver truly innovative drugs and specialise in cancer treatments and other severe, immune, inflammatory conditions.
- 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.
- Initiating and approval routing of change control requests.
- Performing QA evaluation and endorsement/approval.
- Review of associated contractor change control requests.
- Monitoring progress of related action items.
- Recording complaint details.
- 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.
- Review, edit, negotiate 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.
- Draft or review, negotiate with contractors, and recommend approval for Quality Agreements.
- Participating in self inspections as appropriate.
- Participating 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:
- Develop and/or maintain pharmaceutical quality systems, as assigned.
- Author and/or revise standard operating procedures and associated work instructions, as assigned.
- Reviewing and providing recommendations on policies and standards, as assigned.
- Supporting GMP/GDP site inspections, as assigned.
- Maintaining compliance with personal training requirements.
Skills and Requirements:
- BSc (or equivalent) in a technical or scientific discipline.
- Demonstrated pharmaceutical quality experience (equivalent to a minimum of 5 years'
experience), including experience/knowledge of audit, batch record review, change control, complaint handling, investigations and SOP creation and update.
- Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly).
- Must have demonstrated understanding of the processes and interactions essential for
ensuring and maintaining regulatory compliance.
- Must have strong task management skills with the ability to prioritise, schedule, and control multiple projects and resources simultaneously under tight deadlines.
- Must have excellent communication skills, including excellent written, interpersonal,
collaboration, and negotiation skills, with a team-oriented approach.
- Must have exemplary problem solving and organisational skills.
- Must have computer proficiency.
- Must have attention to detail.
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.