Job Title: Quality Associate - Global Biopharmaceutical
Contract : 6 months
Location: Bracknell or Dublin based (Hybrid)
Salary: £37.39 PAYE, £42.89 Umbrella per hour
Job purpose:
1. To ensure compliant and efficient execution of a quality project across the UK and Ireland organizations.
2. Gap assessment of the QMS for a new entity
3. Project planning to ensure effective and compliant integration of current QMS with to be QMS of the established entity.
4. Ownership of the project planning and execution.
5. Implementation of project plan to ensure effective QMS in new entity.
6. Creation of Quality agreements and contracts
Job Responsibilities:
7. Execute elements of the quality management system to support GMDP activities at the Country Organisation and, where required/experienced, support ownership of a quality process or system - this includes understanding and assessment of SOPs, documents, records and metrics related to the systems. Support evaluation any issues/gaps and improvement implementation.
8. To ensure compliant and efficient execution of a quality project across the UK and Ireland organizations.
9. Gap assessment of the QMS for a new entity
10. Project planning to ensure effective and compliant integration of current QMS with to be QMS of the established entity.
11. Ownership of the project planning and execution.
12. Implementation of project plan to ensure effective QMS in new entity.
13. Creation of Quality agreements and contracts
14. Support in audits/ inspections/ self-inspection programme when required.
15. Operate the Country Organisation quality activities following SOP's and using documentation/IT system confidently as required
16. Gain knowledge of IT platforms/applications required to operate tasks in those quality systems
17. Completion of training in compliance
18. Deliver on time for individual actions or commitments - or reschedule appropriately as needed. This includes own training commitments and also actions to support others (e.g. reviews and approvals)
Essential Requirements:
19. 1-3 year experience in the pharmaceutical industry, GxP knowledge
20. Good level of skills in the use of computer based systems and applications
21. Quality System Management
22. Understand Regulatory Environment - Knowledge of GMDP and other regulatory requirements relevant for country organisation
23. Quality Governance/Compliance - Support preparation for audits and inspections.
24. Project management experience for Quality
25. Demonstrate Continuous Learning
26. Interpersonal relationships and collaboration