QA Specialist/Manager - GXP
Permanent - Harrogate
Our Client - a Global Drug Development company are looking to recruit for an experienced QA / GXP Person to work at their modern complex in Yorkshire.
- Guiding, advising, and influencing the organization on a range of compliance and data integrity matters.
- Defines, manages, and executes compliance auditing programmes.
- Fully competent as a Lead Auditor.
- Trains others in the conduct of external and internal audits.
- Conducts specialist audits as necessary (multiple GxPs; Data Integrity).
- Liaises with internal and external parties in order to arrange inspections.
- Conducts preparation for inspections and briefs audit team as necessary.
- Ensures appropriate records are generated and maintained for all inspections.
- Coordinates responses to inspection findings. Ensures findings and responses are recorded in the appropriate system to facilitate tracking.
- Provides guidance on current regulatory thinking to all levels of the organization.
- Performs SOP reviews.
- Ensure knowledge of current regulatory thinking is maintained.
- Plays an active role in external industry regulatory forums.
- Active participant in Process Excellence initiatives.
- Conducts other activities, including GxP audits, as required.
- GXP QA experience essential…
- Bachelor of Science/Arts (BS/BA) degree (Experience may be substituted for education in some circumstances).
- Intimate working knowledge of Client SOPs P&Ps as well as local and international GLPs, cGMPs, GCPs and regulatory agency guidelines as applicable.