GMP Lab Coordinator
Chemical Life Sciences Pharmaceuticals
Salary £25,000 - £35,000
CY Partners have a fantastic opportunity for a GMP Lab Coordinator to join a world-leading global pharmaceutical organisation, at their site in Hertfordshire.
As GMP Lab Coordinator you will have the opportunity to establish and maintain the stability storage and capabilities of the Biopharmaceutical Central Testing Laboratory (BioCTL). These activities include the management of facility, equipment, stability documentation and IT systems (as applicable). You will also have the opportunity to plan and coordinate the Stability program for the BioCTL.
Key Responsibilities will include:
- Overseeing and maintaining the BioCTL Stability studies. This includes management of the stability facilities and equipment, management of stability documentation, management of stability sample inventory, capacity planning for stability studies and operating in a cGMP and QMS compliant manner.
- Prioritising activities, anticipate stability time point clashes and manage the delivery of stability time point testing and data.
- liaising with BioCTL analytical management over the review of data, and with statisticians over the analysis of data.
- Managing stability studies relating to new product and in-licensing projects into the BioCTL
- liaising with stakeholders e.g., External Supply, R&D over initiating new stability studies, the ongoing stability support program, deviations, changes, strategic decisions, stability report completion, study closure and lead responses to all enquiries relating to stability.
- Managing contingency planning and business continuity planning with respect to Stability including contribution to the Governance and Risk Management processes for the BioCTL
- Interfacing with the laboratory service providers over the provision of Out of Hours support and temperature alarm generation and response.
- Ensuring systems and utilities are inspection ready and contribute to Level 1, Level 2, Level 3 and Level 4 corporate, customer and regulatory audits.
- Networking with Quality colleagues in GMS, R&D and Third Parties to ensure that the BioCTL leverages the best practices for stability.
- Generating appropriate stability documentation in support of regulatory submissions.
For further information about the role and to apply contact Helen at CY Partners on 07851246847 or email [email protected] with your CV to apply now.