Head of Quality Assurance - Runcorn, United Kingdom - Fresenius Kabi Limited

Fresenius Kabi Limited

Verified Company

Runcorn, United Kingdom

3 weeks ago

Posted by:

Tom O´Connor

beBee Recruiter

Description

Overview:

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:

Essential Duties and Responsibilities

Ensuring an efficient and effective Pharmaceutical Quality System is deployed in the Runcorn facility, in compliance with current GxP's. Provide strategic plan and expertise for the development and implementation of the site Quality and compliance improvement strategy.
Develop / support strategic quality compliance in all areas of the site as part of the Quality Leadership Team
Support external authority inspections (pre and post inspection) engaging with all site functions
Provides support for the analysis of Inspection Results and response to authorities is timely and commitments are delivered on time
Partners with the Quality Leadership Team to ensure regulatory commitments are consistent with global policies and SOP's

This role is critical in supporting the site and ensures the ongoing supply of quality products and license to operate.

The role requires an individual that has extensive pharmaceutical quality operations experience including experience with good knowledge of the MHRA special's guidance and sterile manufacturing.

- providing a pro-active, Quality support to the businesses manufacturing operation.

Provides expert coaching and mentoring support on all aspects of quality compliance developing quality culture for the site.
Responsible for the generation and evaluation of key performance indicators, GEMBA walks, regulatory compliance and efficiency targets. Responsible for followup of CAPA actions with the respective departments.
Management of site quality metrics and KPI's. Definition and delivery to key stakeholders
Identifies improvement opportunities in monitoring, measurement and trending of KPI's. Drives improvements based on current industry thinking and trends.

Qualifications:

Qualifications / Role Requirements

Previous experience leading a Quality Assurance function, within a pharmaceutical sterile manufacturing site
Demonstrated leadership, interpersonal and influence skills in pharmaceutical industry (preferably within specials manufacture), with the proven ability to teach and coach individuals from diverse backgrounds with varying communication and technical skills.
Bachelor's degree or equivalent education in a related scientific discipline.
Requires a minimum of 7 years' experience within pharmaceutical quality systems / quality assurance, 10+ years relevant experience preferred
Strong knowledge of GxP regulations / industry expectations for Quality Management System processes and associated systems, especially MHRA Guidance for Specials Manufacture
Demonstrated ability to think strategically and to work collaboratively using riskbased, proactive approaches to operations problemsolving
Excellent analytical, written and oral communication skills for both strategic and tactical messages
A qualification in continuous improvement (Lean/6Sigma) would be beneficial