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Total Staff Services are recruiting QC Release Officers for our Client based in Runcorn.
Job Purpose
Reporting to the QC Shift Team Leader for 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 SAPExperience & 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 GuideThis job description reflects the present requirements of the post. It is not intended to reflect the full nature of all the duties required of the post-holder. As duties and responsibilities change and develop the job description will be reviewed as appropriate and subject to amendment in consultation with the post-holder(s).
Hours of work are Monday to Friday (Apply online only)/(Apply online only) rotating weekly
Salary £35,722
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