Our client, a contract testing organisation, is looking for a deeply experienced quality assurance professional to hit the ground running, preparing for and leading departmental and external audits, with full responsibility for GMP compliance and training junior staff in GMP QA. This is flexible as a fixed-term contract or a permanent role, a very exciting opportunity to work either full-time or four days per week in a senior position.
It would suit a consultant able to commit to this time or a very experienced QA professional looking for a fixed-term contract or indeed a permanent role. Site presence is often required.
- Excellent GMP compliance with experience across multiple scientific projects
- Experience in pharmaceutical research/microbiology/in vivo GMP QA is required.
- Suitably qualified or experienced for this level of responsibility in scientific research
- Proficient in ISO 9001 with either manual or automated experience in QMS
- Demonstrable experience leading internal and external audits
- Good leadership capabilities
- Capable of providing sound advice on relevant quality matters.
- Confidence in client-facing responsibilities
- Able to manage and prioritise own workload effectively.
- Promotes a positive, cohesive, team-orientated environment.
- Experience in in vivo toxicology is desirable but not essential
Duties and Responsibilities:
- Undertake the role of GMP Champion within the department, promoting quality management tools and coordinating best practice across the company.
- Ensure all relevant studies are carried out in compliance with GMP
- Ensure departmental work meets internal quality assurance documentation and accepted published guidelines or sponsor protocols
- Provide quality assurance support to departments and clients
- Carry out quality assurance training and support to full-time junior QA Officer
- Lead inspections of departments for compliance with GMP or other quality standards
- Host internal and external inspections, regulatory and clients
- Maintain the Company's supplier approval procedures, inspecting vendors and sub-contract laboratories for approved supplier status.
- Enforce quality assurance review of change control documents, investigation reports associated with non-conformance/out of specification and any associated CAPA
- Conduct activities in accordance with site documents for H&S and quality systems.
- Review regulatory updates including USP/EP and ISO.
- Manage any DIRA reviews and process maps across the company.
- Supervise collation of data for the preparation of reports and for compliance with Quality Procedures for work performed in the department.
Agenda only recruits people with integrity, who are honest and trustworthy and who have a great work ethic. To enable us to hire the very best people, we will conduct a comprehensive background and pre-employment screening, which is an essential part of Agenda's recruitment process.