QC Release Officer

Fresenius Kabi AG; Runcorn; On-site; GBP 80,000 - 100,000; Full time

Job summary

A leading pharmaceutical company is seeking a full-time QC Release Officer to ensure compliance with GMP standards and manage the release process. Responsibilities include reviewing batch documentation, approving products for market release, and supporting quality investigations. Ideal candidates will have a degree in life science and experience in quality assurance, especially in aseptic operations. This role offers a fixed term contract of 12 months with benefits including a contributory pension scheme and tailored training.

Benefits

Contributory Pension Scheme

Life Insurance

25 days holiday

Healthcare cashback scheme

Maternity, Paternity and Adoption Leave

Professional fees paid

Bike to work scheme

Free onsite parking

Employee Assistance Programme

Qualifications

• Graduate with a degree in life science or relevant experience in quality assurance.
• Experience in aseptic operations and compounding activities.
• Understanding of GMP for manufacturing aseptically produced products.

Responsibilities

• Review and approve batch documentation for product release.
• Support investigations of non-conformities impacting product quality.
• Contribute to continuous improvement of the quality system.
• Compile Certificates of Conformance for customer fulfillment.
• Ensure timely processing of outsourced products.

Skills

Attention to detail

Knowledge of GMP requirements

Experience in quality assurance

Aseptic operations experience

Education

Degree in life science or relevant experience

Tools

SAP

Job description

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