Job Description
Join one of Irelands leading Biotech companies as a Compliance Specialist, this is a 12 month hourly rate contract based in Limerick
Main Responsibilities:
1. Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to ensure compliance with established quality standards, policies and procedures.
2. Reviewing and maintaining procedures & policies
3. Collaborate & support communication between Technical Operations & onsite quality & regulatory groups
4. Complete investigations of technical deviations for department issues of non compliance.
5. Manage CAPAs, Change Controls, risk assessments & impact statements
6. Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess for compliance with established quality standards, policies and procedures.
7. Provide tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
8. Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required
Qualification/Experience:
9. Degree in Science or Engineering related field
10. 2+ years Industry experience in similar capacity
11. Excellent time management & attention to detail
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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