|Location: Leeds, West Yorkshire||Salary: £15 - £19 per hour|
|Sector: Life Sciences, Pharmaceuticals, Medical Devices||Specialism:|
|Type: Contract||Contact: Max Noddings|
Title: Sterility Assurance Specialist
Term: 3 Months initial
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!