For GSK Nyon, Kelly Life Sciences is looking for a:
Support the stability program for marketed products, active substances and medical devices that are manufactured on the site: lead annual stability studies, post approval stability, post approval change stability, registration stability, reworked batch stability testing and annual validation stability.
- Elaborate and follow the stability program according to the ICH and regulatory requirements
- Prepare protocol/report stability as author
- Contribute to the approval of stability results
- Lead investigation and manage OOS, OOT, Change Control & CAPA
- Ensure properly escalation of critical quality events to the escalation manager, stability manager and QA Head
- Ensure up to date of the documentation related to stability activity (SOPs, protocols, reports, CMC document, trends….) and its compliance regarding regulatory and QMS requirements
- Work with Regulatory and Technical departments as well as liaising with external suppliers
- Support continuous up to date KQIs related to stability activity
- Support the management of the climatic chambers on the site, as department owner
- Support the stability sample management, reception from manufacturing area, sample labelling prior start, loading and exit from stability chambers, distribution to the QC laboratory, destruction and inventory.
- Respect all GMP standards. GMP knowledge and experience to support the requirements expected by Swissmedic, European union agencies and other regulatory bodies to assure that our products meet all cGMP requirements together with our operations and documentation system.
- University degree in Engineering, Pharmaceutical Technology, Chemistry, Pharmacy or equivalent.
- Min 2-3 year's experience required
- Proven Stability understanding
- Continuous improvement experience (Root cause analysis, 5S, Problem Solving,)
Please apply online, Anais Mieszczak will be pleased to talk with you.