About the Role
This is a contract position lasting 12 months, based in Waterford and working fully onsite. The successful candidate will be responsible for reviewing data in a timely manner to support batch release and stability programs.
Key Responsibilities:
1. Reviewing data generated in support of batch release and stability programs.
2. Experience with Empower is essential. The ideal candidate will have good attention to detail and be able to take ownership and prioritize their workload for deadlines.
3. Familiarity with checking results against trend limits and specifications, identifying deviations and/or lab investigations.
4. Trending of data.
5. Tracking and identifying the level of not right first time (NRFTs) events.
6. Supporting the QC Laboratory and Management.
7. Effective interaction with other departments on matters related to raw materials, intermediates and finished batch releases.
8. Maintaining close contact with Quality Compliance Specialists and QC team Leaders.
9. Maintaining, updating and issuing control prints, methods, specifications and SOP's in compliance with pharmacopeial and regulatory requirements.
10. Assisting with training of analysts in areas of expertise and knowledge, as well as new methods, SOP's and updates.
11. Excellent communication skills.
12. Initiative – being able to work in a self-directed manner to see issues through to completion.
13. Working with the team and prioritizing work.
14. Extensive knowledge of cGMP and GDP in a regulated environment.
15. Working knowledge of quality systems in a regulated environment.
16. Excellent accuracy and attention to detail.
17. Excellent interpersonal skills.