Quality Control Release Officer in Runcorn

Are you an attentive Quality Control Officer or a graduate with a life science degree? 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. Fresenius Kabi is a global healthcare company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition.

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:

• 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.

Benefits:

• No rota'd weekend working and no night shifts.
• 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.

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.