Quality Control Officer - Runcorn, United Kingdom - Fresenius Kabi Limited

Fresenius Kabi Limited

Verified Company

Runcorn, United Kingdom

2 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Overview:
Are you an attentive Quality Control Release Officer?

Reporting to a Quality Control Shift Team Leader, you will be performing duties to comply with the quality system in accordance with GMP standards.

This role will be a full-time role, 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.

With a corporate philosophy of 'caring for life', the company's goal is to improve the patient's quality of life.

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 pertinent 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 nonconformities 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:

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
Attention to detail
A demonstrable ability to communicate effectively
IT literate, including Microsoft Office