QA Microbiologist

Pe Global

Cork

PE Global is currently recruiting for a Microbiologist for the QA Department of our Med Device Clients site in Cork: JOB PURPOSE: 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. ORGANISATIONAL INTERFACES: 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 Sterilization Assurance Personnel, Corporate Sterilization Assurance Personnel. MAIN DUTIES & RESPONSIBILITIES: 1. To support the microbial assurance aspects of the Quality System. 2. To carry out regular microbial monitoring of all clean room facilities and water systems, to analyze the results and recommend corrective action where appropriate. 3. To co-ordinate use of all microbial services. 4. To support the review and development of procedures for all microbial assurance activities. 5. To carry out regular internal auditing of all clean room facilities and other areas. 6. To implement the GMP training program for clean room and other appropriate staff. 7. To be a member of New Product Development teams and undertake cleaning, microbial, sterilization validation as required. 8. To support the release of sterile products. 9. To support the Quality team in the preparation for and performance of all third party inspections and audits as appropriate. 10. To create change controls identifying Microbial impact and necessary actions in line with WW and local procedures. 11. To adhere to the Company’s procedures as detailed in the SOP manual. 12. Maintain a detailed knowledge of AAMI/ISO standards relevant to Sterilization and Environmental monitoring. 13. To support specific projects as allocated by the International Sterility Assurance Manager. 14. All employees are responsible for minimizing both the Environmental and Health & Safety effects of the work that they perform. KEY COMPETENCIES REQUIRED: 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 Bright. __________________________________________________________________________________ QUALIFICATIONS & EXPERIENCE. ESSENTIAL: 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. DESIRABLE: ISO 9001 Lead Assessor qualification. THIS JOB DESCRIPTION IS NOT AN EXHAUSTIVE LIST OF THE JOB HOLDERS RESPONSIBILITIES. Interested candidates should send their CV to Audrey.brennan@peglobal.net or call 0214297900. Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. This job originally appeared on RecruitIreland.com.

2036 days ago