Overview
This range is provided by Sigmar Recruitment. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
Direct message the job poster from Sigmar Recruitment
Executive Consultant: Quality & Regulatory - Pharma, Med Device & Biotech. Perm / Contract. (+353)1 474 4669
Excellent role as a Site Microbiologist for a Medical Device company based in South Dublin. This is a perm role with strong salary and benefits package. In this role you are responsible for ensuring that all products adhere to the specified microbiological and sterilization standards.
Responsibilities:
* Responsible for maintaining up-to-date knowledge of all current relevant worldwide regulatory requirements that relate to products manufactured at the site
* Manage daily operations of the in-house microbiology laboratory, ensuring timely and accurate testing and equipment maintenance
* Setting of appropriate microbiological quality standards for all products, and implementation across the site in compliance with all sterilisation and environmental monitoring requirements
* Work with cross functional teams to support the radiation sterilization validation and routine monitoring for all products.
* Responsible for overseeing, approving and maintaining the Dose establishment, Bioburden testing, sterility testing, endotoxin testing and environmental monitoring programs for the site.
* Responsible for Risk assessments to support the sterility assurance activities on site.
* Responsible for determination of sterility assurance requirements for the site change control program.
* Responsible for all Sterility assurance and microbiology related out of specification investigations, non conformances and CAPA.
* Responsible for the sterilization product release program for all products from the site
* Act as microbiology and sterilization technical specialist and SME for the site and participate in audits to represent the sterility assurance function.
* Act as an internal auditor supporting the site internal audit program.
* Responsible for the validation and maintenance of environmental monitoring programs, and environmentally controlled manufacturing areas for the site.
* Any other reasonable duties which may be required by management from time to time
Educational Requirements and Relevant Experience:
* Degree in Science or related Quality discipline specialising in Microbiology
* 8+ years experience in a similar role, preferably in a medical devices, pharmaceutical or biologics manufacturing environment, experience supervising personnel and managing projects.
* Radiation and terminal sterilization experience would be advantageous
* Thorough knowledge of sterilization and microbiology requirements for terminally sterilized medical devices including ISO 11137, ISO 11737, ISO 14644, FDA and EUMDR requirements along with other relevant standards.
Seniority level
* Mid-Senior level
Employment type
* Full-time
Job function
* Quality Assurance
Industries
* Medical Equipment Manufacturing
* Pharmaceutical Manufacturing
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