Contact: Bimi Felix
Telephone: 086 8395533
Microbiologist - Contract
Our client, a medical device company in Cork are currently looking to recruit a Microbiologist for their site on a contract basis.
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.
Microbiology Team Personnel, International Sterility Assurance Manager, Cleaning & Packaging Staff, Sterilization Sub Contractor, QC Laboratory Sun-Contractor, QA Engineers, New Product Development Engineers, Manufacturing Engineers, DePuy Synthes WW Sterilization Assurance Personnel, J&J Corporate Sterilization Assurance Personnel.
Main Duties & Responsibilities:
- 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.
- High Attention to Detail Pro-active approach to Work
- High Standards Flexible
- Excellent Communication Skills Influencing Skills
- (Written & Oral) Team Player
- High level of Numeracy Highly Computer Literate
- Planner & Organiser B
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.
- ISO 9001 Lead Assessor qualification.
For further information on this Microbiologist role in Cork please contact Bimi Felix on 086 8395533 / firstname.lastname@example.org
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