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Job Details

Senior Sterility Assurance Quality Manager EMEA

Company: Baxter Healthcare Ltd
Location: Newbury
Reference: 18000EIA
Closing Date: 03 Sep 18
Type: Full Time
Salary (£): Competitive
Benefits:

Job Summary:

The job as Senior Sterility Assurance Quality Lead EMEA at Baxter is a great opportunity to develop your professional career in our Compounding business.

Requirements:

About Baxter
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
 
 
A Career That Matters
Baxter’s employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.
 
The job as Senior Sterility Assurance Quality Lead EMEA at Baxter is a great opportunity to develop your professional career in our Compounding business.
 
Role Responsibilities

  • Providing technical expertise and supporting our sites in Europe on all sterility assurance aspects.
  • Be an effective source of information and advice on sterility assurance and will positively contribute to the EMEA Compounding Quality Management Team, ensuring that all sites maintain a robust, effective and compliant sterility assurance and environmental control and monitoring process in conjunction with the global strategy.
  • Ensuring an effective sterility assurance and environmental monitoring programme is deployed in all European Compounding Facilities, in compliance with current GMP and the Baxter global strategy
  • Providing Microbiological expertise and support for the sites for corrective actions improvements and changes, where required reviewing and approving change control for sterility assurance compliance,
  • Acting as a SME on sterility assurance in the EMEA Compounding team and as a primary Point-of-Contact for the relevant Regulatory Agencies during the on-site inspections and the relevant follow-up
  • Providing Microbiological training for operational and quality staff
  • Ensuring sterility Assurance is maintained throughout the supply chain
  • Collating the environmental monitoring data and Management Information and Statistics
  • Supporting the Global compounding organization on standardization of sterility assurance practices and identification/implementation of new technology for microbiological testing and environmental control.
  • Travelling to various sites including Thetford, Mount Vernon, Oxford, Stockport, Liverpool, Swinford and Dublin and other countries.

 

Qualifications

  • A microbiology graduate with experience of aseptic techniques.
  • Significant experience in implementing environmental control programs and OOL investigation and correction
  • Extensive experience of microbiology in an aseptic facility
  • You bring a strong operational experience track record preferably in an aseptic manufacturing background and have Lean manufacturing experience
  • You preferably bring Pharmacy Compounding experience


Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, colour, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.

Apply for this job: Senior Sterility Assurance Quality Manager EMEA

Contact Information:

Address:  Head Office
Wallingford Road
Compton, Newbury
RG20 7QW
England
Tel:  +44 (0) 1635 206 000
Fax:  + 44 (0) 1635 206 115
Website:  Visit Our Web Site

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