Quality Assurance Manager
Competitive salary circa £58,000 per annum
This is a rare job opportunity for a QA Manager to join a world class, global pharmaceutical company at their site in Liverpool. Reporting directly in to the QP, the QA Manager will provide QA oversight for all IT systems. You will also be part of a Global team, offering long term career progression opportunities.
Responsibilities of the QA Manager are:
• Role to encompass process automation, laboratory equipment, e-compliance, site systems such as SAP, GLIMS and Sentry and will be QA point of contact for IT projects
• e-Compliance – ensure GMP critical computer systems are implemented and maintained in accordance with GAMP5 guidelines. eg GLIMS, SAP, Sentry etc.
• Maintain site QA oversight of IT Quality Systems, i.e. changes, incidents and CAPA actions
• Automation – Provide QA oversight for process automation systems such as PCS, MES and OSiPi. Be key contact for compliance of Automation department and provide guidance around changes and sustaining the systems in a compliant manner
• Identify and coordinate the Quality focused management of risks associated with electronic projects and life cycles changes, including escalation to site QO management potential quality impact of risk of automation systems at the Liverpool site to enable timely address and mitigation as required.
• Lead Data Integrity compliance
• Provide oversite of data integrity requirements and how manual controls have been implemented where the systems do not meet the required standards QA GLIMS oversight of process for administration of passwords, training and compliance of system.
• Responsible for QA oversight of approval of LRF’s for system updates and changes.
• Responsible for ensuring all stand-alone equipment is updated and documented in accordance with summer and winter GMT.
The ideal candidate for the QA Manager will have:
• An MSc or PHD in a relevant scientific subject.
• Knowledge of GAMP5 and CSV is essential for the role
• Experience of GMP systems, multiple IT applications and an understanding of QA in a GMP environment is essential.
• Ideally an experienced pharmaceutical QA Manager who is tech savvy
If you are looking to join a world leading pharmaceutical company, with exciting career prospects, then please apply today!