Join one of Ireland's leading Biotech companies as a Compliance Specialist. This is a 12-month hourly rate contract based in Limerick.
Main Responsibilities:
* Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents, and Engineering Documentation to ensure compliance with established quality standards, policies, and procedures.
* Review and maintain procedures & policies.
* Collaborate & support communication between Technical Operations & onsite quality & regulatory groups.
* Complete investigations of technical deviations for department issues of non-compliance.
* Review and approval of preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess compliance with established quality standards, policies, and procedures.
* Provide tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
* Maintain knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance-related activities as required.
Qualification/Experience:
* Degree in Science or Engineering-related field.
* 2+ years industry experience in a similar capacity.
* Excellent time management & attention to detail.
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