The main purpose of the role will be:
• Based on technical, regulatory and business requirements, to provide advice on GMP and product quality in support of the supply and use of starting materials, intermediates and APIs.
• To collate, review and approve the documentation required for batch disposition and perform usage decision using the SAP/MERPS system.
• To review and approve documentation for change control purposes, i.e. planned change (RMA, PMA, plant process changes) and deviations (notifications, out of calibration / time tolerance) and to check and approve GMP documentation.
• To identify and recommend improvements to GMP compliance within Operations by monitoring performance against improvement targets and reviewing quality data for Area Quality Council meetings.
• To contribute to the generation, administration and review of PPR (Periodic Product Review) reports.
• To perform quality checking of production batch records to ensure compliance with GMP throughout manufacture.
• To carry out Level 1 & 2 audits within the site program as directed.
• Support external audit preparation and delivery of audit control room functions.
• Support site GPS Improvement programs.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Degree or equivalent in a Science subject with previous Quality experience gained through working within the Pharmaceutical industry.
- Excellent knowledge of GMP and QMS is required.
This is an excellent opportunity to join a multi national company in the beautiful Cumbria region.
Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference DH41232 in all correspondence.
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