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Sterility Assurance Specialist

Location: Leeds, West Yorkshire Salary: £15 - £19 per hour
Sector: Life Sciences, Pharmaceuticals, Medical Devices Type: Contract
Contact: Max Noddings Job Published: 18 days ago

Title: Sterility Assurance Specialist

Location: Leeds

Term: 3 Months initial

Rate: £15-19ph

Sterility Assurance Specialist needed for a multinational pharmaceuticals and medical devices organisation based in Leeds who are looking to employ a Sterility Assurance Specialist with a high attention to detail, pro-active approach to work to assist the Sterility Assurance and Microbiology team.

What the role entails:

Some of the main duties of the Sterility Assurance Specialist will include:

  • To support the microbial assurance aspects of the Quality System.
  • To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate.
  • To co-ordinate use of all microbial services.
  • To support the review and development of procedures for all microbial assurance activities.
  • To carry out regular internal auditing of all clean room facilities and other areas.
  • To implement the GMP training program for clean room and other appropriate staff.
  • To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required.
  • To support the release of sterile products.
  • To support the Quality team in the preparation for and performance of all third-party inspections and audits as appropriate.
  • To create change controls identifying Microbial impact and necessary actions in line with WW and local procedures.
  • To adhere to the Company's procedures as detailed in the SOP manual.
  • Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring.
  • To support specific projects as allocated by the International Sterility Assurance Manager.
  • All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform.

    What you need to be the successful Sterility Assurance Specialist:

In order to be the successful Sterility Assurance Specialist and have a chance to gain such an exciting opportunity you will ideally need to have the following:

  • A degree level qualification in a medical related field, 2:1 or higher
  • Post qualification experience as a Microbiologist in a medical device, pharmaceutical, or similar regulated industry.
  • Familiarity with microbiological aspects of GMP regarding sterile medical devices.
  • Experience of conducting GMP audits, internal and relevant external audits.
  • Ideally qualified to Degree level or in Engineering/Mathematics/Physics although relevant, equivalent experience is acceptable

This really is a fantastic opportunity for a Sterility Assurance Specialist to progress their career. If you are interested please apply as soon as possible as this position will be filled quickly so don't miss out!

This advert was posted by Gold Group - one of the UK's leading niche recruitment consultancies. We span a variety of specialist industries and are the recruitment company to help you find your next career opportunity. We pride ourselves on our commitment to candidates and stick to our ethos of finding the right role for the right person. Visit our website or get in touch today to discuss this role, find out what else we've got or just for a chat about the state of your industry. Services advertised by Gold Group are those of an Agency and/or an Employment Business. Please be aware that we receive a high volume of applications for every role advertised and regularly receive applications from candidates who exceed the job credentials. We will only contact you within the next 14 days if you are selected for an interview. A copy of our privacy policy can be found here: https://www.goldgroup.co.uk/about-us/privacy-policy. Gold Group is an equal opportunity & diversity employer. A copy of our equal opportunity & diversity policy can be found here: https://www.goldgroup.co.uk/about-us/equality-and-diversity-policy

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