The purpose of this role is to support the Microbiology team in the application and practice of microbial assurance as applied to the design, manufacture and sterilisation of implants while ensuring that the company meets all Corporate, FDA, Department of Health & Medical Device Directive and European Standards requirements.
- 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 analyse 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.
Qualifications & Experience:
- Degree level qualification in Microbiology or equivalent
- Minimum 3 years 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.
For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email email@example.com
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