Description Overview
Reporting to the QC laboratory Manager, responsible for supervising the Routine Stability Testing and Stability Coordination teams.
Ensure that long term, on-going stability programme for products marketed by Perrigo and contract customers is managed efficiently, and in compliance with cGMP/ICH requirements.
Chemical testing, paperwork and conclusions are right first time, tested and passed within lead times.
Scope of the Role
Planning and Schedule Adherence:
1. Manage people and equipment resources appropriately to ensure current and future demand can be accommodated
2. Manage day to day workload and scheduling ensuring that batches are consistently set down on stability, tested at each time point, passed, and concluded inside lead times
3. Measure defined KPI to manage the throughput and quality output of the function
4. Actively manage technical, relational, and organisational issues which may cause delay, identifying both root cause and appropriate short term and long-term corrective actions to prevent reoccurrence
5. Proactively manage team holiday, absence, and wellbeing to ensure adequate staffing levels
People and Team Management:
6. Provide clear direction to the team in alignment with business and departmental objectives
7. Personally demonstrate and foster the Perrigo Core Values in all aspects of individual and team working
8. Ensure all staff have a development and training plan and clear personal objectives to develop a strong, motivated team
9. Manage day to day performance of the team, ensuring all team members can contribute effectively – provide recognition and reward for good performance and ensure that improvement measures are in place for under-performance
10. Flex resource deployment to provide Right First Time, On Time testing
11. Actively focus on continual improvement of employee engagement
Cross Functional Working and Interaction:
12. Maintain positive and effective relationships with all other functions, specifically, packing, project management and regulatory
13. Work collaboratively in cross functional teams to deliver business objectives and resolve problems
14. Use principles of voice of the customer to identify requirements and expectations of internal customers
15. Communicate function performance clearly
16. Ensure mechanisms are in place for early communication of problems that may impact other departments and steps taken to resolve
Compliance to cGMP:
17. Ensure that stability studies are set down, tested, and concluded in line with current procedures and these procedures are aligned with cGMP, ICH, and relevant quality standards
18. Ensure all methods are suitable and validated
19. Actively manage data integrity
20. Ensure that stability chambers are maintained
21. Investigate all non-conformance and out of specifications to identify root cause and implement corrective actions
22. Investigate all adverse genuine stability trends and make recommendations i.e., reporting failures to DMRC, reducing shelf life, changing packaging materials
Innovation and Operational Excellence:
23. Use the principles of operational excellence and lean management in operation of the function: - visual management, managing for daily improvement, etc
24. Measure the performance of the function for quality timeliness and efficiency to identify improvement opportunities
25. Stay abreast of industry innovation in testing, analytical methods, and cGMP
Budgetary Control:
26. Manage overtime effectively ensuing any overtime is agreed in advance
27. Manage and control spending for consumables associated with all testing activities
28. Identify capital expenditure items required to continue the effective functioning of the department prior to breakdown
29. To undertake such other reasonable duties as may be required from time to time to support the Perrigo business.
Experience Required
30. Minimum of a Scientific degree of equivalent, although relevant experience and demonstrated competence may be considered in place of formal qualification
31. 5 years’ experience of working in a cGMP or other regulated laboratory environment
32. 3 years’ supervisory experience
33. Familiarity and experience with both instrumental and wet chemistry techniques
34. Understanding of data integrity principles and control methods
35. Familiarity with statistical techniques
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV