Reporting to a QC Shift Team Leader, the QC Release Officer will be performing duties to comply with the quality system in accordance with GMP standards. This role is a 12-month fixed term contract and is full-time, 37.5 hours per week Monday-Friday, 7am - 3pm alternating with 3pm - 11pm on a weekly basis and based in Runcorn.
We are proud to foster a workplace free from discrimination. Diversity of experience, perspectives, and background create a better work environment and better products. Whatever your identity, we will give your application fair consideration.
Responsibilities
* Reviewing all batch documentation as part of the product release process, in order to assess whether a product is compliant with a given specification
* Approving individual batches for release to market or further internal use
* Supporting investigations of non-conformities that may impact upon the release process, product quality or compliance of the ASU facility
* 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 FK responsibilities to its customers
* Operating the Quality Assurance databases 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 Fresenius Kabi 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
Qualifications and Experience
* Are you an attentive Quality Control Officer or a graduate with a life science degree?
* Degree in a life science subject or appropriate experience of working in a quality assurance or control related function within either the pharmaceutical/ healthcare related industry
* Experience of aseptic operations is necessary, if possible aided by experience in aseptic compounding activities
* Very good knowledge of GMP requirements specifically for manufacturing and control of aseptically produced products as laid down in the Orange Guide
* No rota'd weekend working and no night shifts
Benefits
* Contributory Pension Scheme (rises with service)
* Role specific tailored training and development plan
* Life Insurance (4 x salary, death in service)
* 25 days holiday (rises to 27 after 5 years service) and ability to buy/sell holidays
* Healthcare cashback scheme (including dental, optical & alternative therapies)
* Maternity, Paternity and Adoption Leave
* Professional fees paid
* Bike to work scheme
* Long Service Awards
* Employee Assistance Programme
* Free onsite parking and subsidised canteen
* Blue Light Card
* Charity Fundraising & Volunteer Days
* Company funded family days out
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