Senior Stability Coordinator
8 months ago
**Description Overview**:
To co-ordinate the Stability function in ensuring provision of long term, on-going stability testing for products marketed by Perrigo and contract customers.
Ensure that the on-going stability programme at Perrigo Braunton is managed in compliance with GMP requirements. Management of sample and study, chamber and facility, documentation and data.
**Scope of the Role**:
- Identifying all requirements for stability testing ongoing and ensuring performance against schedule is recorded, tracked and monitored.
- Responsible for the maintenance of the Stability Testing Programme. Collaborating with QC supervisor to ensure stability testing is scheduled and completed in a timely manner.
- Preparation of stability protocols.
- Review and approval of completed Stability protocols and Conclusions.
- To maintain database records and protocols for all batches being placed on test.
- To ensure that samples are obtained and added to the stability testing programme for routine studies and non-routine events, e.g. New Product Introduction, Process Validation, Change Control activities.
- Supports collection of Stability information during internal and external Inspections in QC Lab, include MHRA.
- Ensuring that compliance of Stability chambers is maintained, and samples are placed on stability at correct time.
- To assist in the resolution of Out of Specification results.
- Coordinating and conducting risk assessment related to QC testing in support of change.
- To undertake such other reasonable duties as may be required from time to time in order to support the Perrigo business.
**Experience Required**:
- Experience in conducting pharmaceutical stability testing.
- Effective communication - written, verbal, and interpersonal communication skills are essential - can convey information positively, succinctly, objectively.
- Must be proficient in computer software programmes such as word and excel.
- Demonstrate ability to meet schedules and timelines and handle multiple priorities to a high standard within a timely manner - focussed drive to tasks / projects.
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