Stability Specialist - Pfizer, Grange Castle
CPL, in conjunction with our client Pfizer, require Stability Specialists to join the QA team at their biologics plant in Grange Castle. There are 2 roles available.
The role will be to provide for the appropriate management and technical expertise in order to support and maintain the stability programs conducted by the QA Stability group and designed to support new and existing product licensing requirements. The role requires a close working relationship with Quality Control, Manufacturing, Regulatory Affairs and Development groups.
- Provide technical expertise in the design, implementation and management of stability studies, including relevant documentation, in line with current regulations, PQS and business needs. All related procedures and documentation to be maintained accordingly.
- Facilitate the creation and maintenance of the schedule for completion of the Annual Stability Program.
- Key role in any atypical or out of specification investigation.
- Facilitation and technical support for Stability Review Board (SRB) process.
- Authorship, review & approval of stability sections of regulatory filings.
- Support the introduction of new products.
- Trend reviews and SQRT (Site Quality Review Team) updates where required
- Third level qualification
- 3+ years working in a QC environment, ideally with some experience of Stability testing.
- Strong technical writing skills.
- LIMS experience
These are initial contract roles.
Send CV to email@example.com