Job Description
Conformance & Training Manager
We are currently recruiting for an exciting opportunity for a Conformance & Training Manager to join our Aseptic Services Unit (ASU).
Reporting to the Senior Production Manager, you would be responsible for the leadership, direction, motivation and management of the Conformance and Training team, enabling the Aseptic Unit to deliver the highest quality product in an efficient and cost-effective manner.
The role is full-time, Monday - Friday, working all bank holidays and is based at our Head Office in Runcorn, Cheshire.
Fresenius Kabi is a global healthcare company that specialises 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 comprises a comprehensive range of I.V. generic drugs, infusion therapies and clinical nutrition products as well as the medical devices for administering these products.
At our Runcorn site, we have one of the largest Aseptic Compounding units in the UK, producing Parenteral Nutrition.
Responsibilities
* Directly manage the Conformance and Training team, providing line management, coaching and direction
* Provide support in all areas of compliance, including reviewing trends in deviations and recommend actions for improvement
* Compliance with company policies, legislative requirements include financial, health and safety, cGMP, cGDP and Home Office regulations
* Manage internal audits to support the identification, root cause analysis and closure of non-compliance issues and to support continuous improvement of the QMS
* Represent the ASU in internal, global, MHRA and any other regulatory body audits
* Ensure the team deliver events and actions on time, every time, with thorough investigation
* Own understanding of all critical ASU related events in Kabitrack and ensure all ASU event IIA’s are completed on time
* Conduct quality risk assessments and gap analysis of the current quality system relating to the ASU and generate appropriate actions plans
* Provide advice and guidance to ASU management team in all applicable Quality guidelines and regulations including new projects
* Review and improve KPI reporting for TrackWise and Ulysses system, present at the Quality/Management Review Meetings
Qualifications/experience
* Extensive experience in the Pharmaceutical industry
* Sterile manufacturing experience is preferable
* Problem solving skills and excellent communication skills
Benefits
* Private healthcare
* 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
* 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.