My client is a clinical stage biopharmaceutical company, focused on novel cancer therapies. With offices across Europe and the US, and an exciting pipeline of products going into phase II and III trials, they are now looking to expand their quality assurance team.
- Ensure all work is compliant with cGCP, cGMP, SOP, and regulatory requirements.
- Provide support for quality incident root cause analysis, risk assessments and approvals.
- Handling and approval of CAPAs (corrective action, preventative action) and deviations.
- Review and approvals of change controls for related documentation for compliance GMP/GCP requirements.
- Conduct internal audits and support regulatory and customer audits, and participate in external audit program.
- Preparation, issue and distribution of SOPs.
Qualifications and Experience:
- Bachelor's degree in relevant scientific discipline.
- 1-3 years' experience within pharmaceutical quality.
- Experience with implementation and management of CFR 21 part 11 Quality Management System.
- Experience in the writing of SOPs, as well as experience with CAPA, deviations, and change controls.
- Experience in audits, with an external auditing qualification desirable.
If you have any questions, please contact Nick Skouros, specialist recruitment consultant at firstname.lastname@example.org.