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Details

Engineering Compliance Specialist


Reference:KG-ARRX-145312 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

This fantastic company offer a unique, world-class working environment. They’re an award winning pharmaceutical and biotechnology company. In the rople you will be responsible for ensuring cGMP compliance the onsite Tech Ops Engineering & Automation Department.

Essential Duties and Responsibilities include, but are not limited to, the following:
• Facilitates reviews and revisions of Department related SOP's, life cycle documents, plans and policies for each group within the Department.
• Acts as a liaison between Engineering & Automation and onsite quality and regulatory groups to define and address compliance related items.
• Identifies opportunities for continuous improvement of compliance and leads improvement initiatives.
• Provides support, information, and assistance to individuals, groups and management with the initiation, review, submission, and follow-up of documents such as Change Controls, EOE’s, NOE's, DNF's, risk assessments, impact statements and corrective/prevention action plans.
• Participates in investigations and root cause analysis for department issues of non-compliance.
• Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc. to assess for compliance with established quality standards, policies and procedures.
• Provides tracking and trending for maintenance of related compliance activities i.e. quality instances and PERs.
• Participates in and obtains results of department quality and regulatory audits.
• Specifies and coordinates training, OJT and SOP, for Automation, Engineering and contracted personnel.
• Maintains knowledge of current good manufacturing practices (cGMPs).

Education and Experience:
• Requires BA/BS (engineering or scientific related field preferred) and 3+ years of related experience working in a cGMP environment or in the operation of an industrial facility. May substitute relevant experience in lieu of education.
• Ability to work on own initiative, without direct supervision from management.
• Team player with an ability to work well across various departments on site as well as business partners.
• Excellent written, presentation, communication and investigation skills.
• Deadline focused individual.

If you would like further Information you can contact the recruiter directly:

Kevin Silke | Tel: +353 (0) 1 507 9255