Compliance Specialist

Job Description

My client, an industry leading Limerick Pharmaceutical company, is looking to hire a compliance specialist to help aid their exciting projects.

This is a long term contract position with rates depending on experience.

Responsibilities:

• Completes investigations of technical deviations for department issues of non compliance. Ensures CAPAs are identified as appropriate and are implemented as planned; in addition, ensures CAPAs have the intended effectiveness.
• Acts as a liaison between Technical Operations and onsite quality and regulatory groups, as well as other departments across the company, with respect to all quality instances and compliance support.
• Provides support, information, and assistance to individuals, groups and management with the initiation, authorship, review, submission, and follow-up/completion of documents such as Change Controls, risk assessments, impact statements and corrective/prevention action plans.
• Provide periodic review of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, Life Cycle Documents and Engineering Documentation, etc. to assess for compliance with established quality standards, policies and procedures.
• 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.
• Maintains knowledge of current good manufacturing practices (cGMPs) and execution of any other GMP compliance related activities as required.
• Continuous Improvement Implementation.

Education & Experience:

• Minimum of BA/BS in Engineering/Science discipline with 2+ years experience working in a cGMP environment.
• Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
• Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments.

For more information on the role please feel free to contact our specialist engineering recruiter Gerard Crowley by calling 021 2 300 300

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

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