1. Job Title: Scientist 2 - Stability
2. Contract: 12 months
3. Location: Deeside
4. Pay: £134 p/d
SRG are partnered with a global medical products and technologies company. Our client is focused on solutions for the management of chronic conditions, with leading positions in advanced wound care, ostomy care, continence care, and infusion care.
We are seeking a Scientist to join their Deeside team.
Duties and Responsibilities:
To be responsible for maintaining compliance within the Stability Suites, Stability Laboratory and associated areas to support the determination of product shelf-life and product labelling. The focus of this role will be on Non-Conformance (NC), Corrective Action/Preventative Action (CAPA), and Out of Specification (OOS) investigations.
5. Maintain compliance to ISO13485 & ISO9001 standards in accordance with GLP/GMP compliant procedures.
6. Support maintenance, calibration, documentation and updating quality records for Stability equipment.
7. Support any on-site maintenance, service and calibration activities performed by external vendors.
8. Act as Subject Manner Expert (SME) and write Quality documentation such as Change Control Requests (CCRs), Non-Conformances (NCs), Corrective Action/Preventative Action (CAPAs) and Laboratory Out of Specifications (OOS'), ensuring accurate and thorough investigations are complete within required timeframes, incorporating problem-solving and troubleshooting for future improvements.
9. Monitor compliance KPIs within the Stability department and proactively update the management team with trends and improvement initiatives.
10. Ensure the Stability department is audit ready at all times.
11. Supports and provides information for internal and external audits where required in a timely manner.
12. Conduct training sessions on compliance for the Stability department.
13. Support global testing laboratories with compliance requirements as needed.
14. Actively execute improvement ideas (Lean/6S) for the Stability laboratories and suites.
15. Actively supporting with the implementation of the LIMs system.
16. Support bringing in new equipment when required, through planning and execution of Installation, Operational and Performance Qualification activities, liaising with vendors as per company procedures.
17. Ensure the Stability lab, Stability Suites and storerooms are maintained as a safe and compliant working environment, raising near misses where needed.
18. Supporting any other tasks required by the Laboratory Manager/Team Leaders.
Skills & Experience:
19. Preferably 2-3 years' experience working in Medical Device/Pharmaceutical Industry within an R&D/product development or quality department role.
20. Experience in quality and compliance
21. Ability to react and respond positively to changes in priority and workload.
22. Competent in following and adhering to pre-determined stability study protocols, SOPs, OCIs and TDs.
23. Basic experience in the utilisation of computerised systems to manage data and information.
24. Good working knowledge of Microsoft Office - specifically Word and Excel.
25. Understanding of compliance with FDA and European Regulations (ICH), Quality Systems and GMP Guidelines.
26. Proactive and positive mindset with an attitude that is open to change to embrace new ways of working and improvements.
27. Proven experience leading thorough Quality investigations and implementing effective preventative and corrective measures.
28. Strong communication skills to effectively collaborate cross-functionally.