Job Description
We are seeking a highly skilled Compliance Specialist to join our team at one of Ireland's leading Biotech companies. This is a 12-month hourly rate contract based in Limerick.
Main Responsibilities:
* Periodically review department documentation and records, including Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents, and Engineering Documentation, to ensure compliance with established quality standards, policies, and procedures.
* Maintain and review procedures and policies.
* Collaborate and support communication between Technical Operations and onsite quality and regulatory groups.
* Conduct investigations into technical deviations for department issues of non-compliance.
* Manage CAPAs, Change Controls, risk assessments, and impact statements.
* Review and approve preventative maintenance records/work orders (corrective and scheduled) on the CMMS system to assess compliance with established quality standards, policies, and procedures.
* Track and trend maintenance of related compliance activities, such as quality instances and PERs.
* Maintain knowledge of current good manufacturing practices (cGMPs) and execute 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 and attention to detail.
This role requires strong analytical and problem-solving skills, with the ability to work independently and collaboratively as part of a team. If you have a passion for ensuring the highest levels of quality and compliance, we encourage you to apply.