Overview:
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 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. The company’s products and services are used to help care for critically and chronically ill patients.
Our product portfolio included a comprehensive range of IV generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products.

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
• 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.

• 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 SA