Total Staff Services are looking to recruit a Fixed Term Contract QC Release Officer (12 months) for our client based in Runcorn.

Reporting to the QC Team Leader for the day-to-day operational duties, the QC Release Officer is responsible for performing all necessary duties in relation to product release in compliance with the quality systems in place in accordance with cGMP and ISO standards.

Main Accountabilities

• Reviewing batch documentation as part of the product release process, in order to assess whether a product is compliant with a given specification
• Determining product disposition; either release to market or for further internal use, or rejection
• Supporting investigations of non-conformities that may impact upon the release process, product quality or compliance of the ASU facility
• Contributing to Team KPI''s for QC efficiency and OTIF in relation to product release
• Contributing to the continuous improvement of all aspects of the quality system to ensure departmental objectives are met and compliance with regulatory requirements is consistently achieved for the ASU
• Compiling Certificates of Conformance as required to fulfil clients responsibilities to its customers
• Operating the Quality Assurance databases to ensure appropriate documentation of events and to support QA in publishing appropriate trends within the business
• Interfacing with other departments including attendance at meetings to ensure that the requirements of the clients QMS are met
• Conducting additional duties as required to support colleagues in the effective execution of their duties
• Ensuring outsourced products are processed in a timely manner and made available for use with transactions performed on SAP

Experience & Qualifications

• Degree in a life science subject or appropriate experience of working in a quality assurance or control related function within either the pharmaceutical/ healthcare or related industry
• Experience of aseptic operations is desirable, if possible aided by experience in aseptic compounding activities
• Good knowledge of GMP requirements specifically for manufacturing and control of aseptically produced products as laid down in the Orange Guide

Salary -37,062

Hours - Rotating Mon - Fri (Apply online only) - Mon -Fri (Apply online only)hrs

2 years experience in QC or strong cGMP in Production is essential