Senior Quality Specialist

12-month FTC

Location: Runcorn, Cheshire.

SRG are looking for a Senior Quality Specialist to join a global pharmaceutical company based in Runcorn, Cheshire. As a senior quality specialist, you'd be responsible for helping to develop and design the Quality management system, as well as controlling and issuing cGMP documentation to help support the compliance and quality of life saving pharmaceutical products!

This role would suit a quality professional, ideally from within the Pharma industry, with a full understanding of GMP and data integrity regulations. At least 2-3 years' experience helping manage QMS processes including CAPAs, Change controls and Deviations. Experience with document controlling would also be desirable.

Key Responsibilities will include:

To design, develop and manage Quality Systems and associated documentation to ensure compliance with Regulatory Standards and Corporate expectations, including change controls, CAPAs and Deviations, as well as QMS performance and audit control.

To generate, issue and control CGMP documentation to support existing Quality Systems and processes.

To support continuous improvement of quality documentation and processes to ensure compliance with CGMP.

To design and deliver CGMP and Quality Systems training in line with Site requirements.

To carry out internal and external audits in line with plan. To act as lead auditor, to identify, action and close out all non-compliance issues with adherence to schedule.

To maintain and update information on latest Regulatory standards for use by company personnel.

Candidate Requirements:

Full understanding of CGMP.

Knowledge of Quality Systems / documentation (At least 2 years' experience, 4 desirable)

Knowledge of QMS Processes such as Change Control, Deviation, CAPA etc.

Audit best practices.

Knowledge of Pharmaceutical GMP regulations (EU & USA)

To apply click the link or send your CV

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy