Senior Stability Coordinator

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

• Ideally BSc or equivalent in a relevant scientific discipline. Consideration will be givento candidates who meet all other requirements and possess a wealth of highly pertinent experience, e.g. cGMP, cGLP in a pharmaceutical context.
• 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.