Job description
Are you an attentive Quality Control Team Leader?
Reporting to Head of QC, the QC shift Team leader is responsible for performing all Quality Control duties in compliance with GMP and ISO standards within their designated shifts. 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:
- Leading and coordinating the Quality Control shift team to endure efficient running of the QC department and deputising in the absence of the Head of QC
- Ensuring sufficient QC capacity is available to cover workload
- Maintenance of team efficiency in order to ensure departmental KPIs are met without compromising quality levels
- Working closely with production shift managers to align work and priorities and advise on manufacturing product quality issues
- Managing team personnel including performance management, personal development plans, annual reviews, absence management and training
- Managing team development to maintain employee engagement and increase departmental knowledge
- Applying product disposition to individual batches, following approved processes and specification and release to market, once satisfied that product is compliant
- Supporting investigations of non-conformities that may impact upon the release process, product quality or compliance of the ASU facility
- Ensuring the Quality management team are made aware of any major/critical events which require investigation
- Evaluating facilities management data and ensuring required action is taken in real time in collaboration with Technical and Production departments
- Contributing to the continuous improvement of the Quality Control function to ensure departmental objectives are met
- Collaboration in the continuous improvement program to support improvements in the manufacture and supply of products
- Ensuring compliance with regulatory and company QMS requirements including routine monitoring of team compliance, driving improvement where required
- Minimum of a Degree in a life science subject or extensive experience of working in a quality assurance or quality control related function within the pharmaceutical/ healthcare related industry
- Supervisory experience
- Advanced knowledge of GMP requirements an MHRA Specials Guidance is desirable
- Experience of aseptic operations is desirable