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Compliance Specialist

ID
14325
Location
Limerick
Role Type
Contract
Contact
Hannah Doyle
Email
engineering@hero.ie
Phone
+353 86 107 0950
LinkedIn
click here
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Compliance Specialist

 - Technical Operations (Automation, Engineering & Facilities)

The Compliance Specialist, Technical Operations is a member of the Technical Operations Team (Automation, Engineering & Facilities) and is responsible for operations support and compliance related activities for the manufacturing of products. 

Essential Duties and Responsibilities include, but are not limited to, the following:

  • 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 Documetation, 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.

Knowledge, skills and abilities:

  • Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
  • Proficient in Excel, PowerPoint, Visio, Word, etc. m addition to experience working within shared work environments.
  • Strong interpersonal, written, presentation, communication and investigation skills with the ability to engage with a diverse range of individuals across all levels of the organisation.

Education and Experience:

  • Specialist; minimum of BA/BS in Engineering/Science discipline with 2+ years experience working in a cGMP environment.

Our Vision: To be recognised as the best STEM Contracting & Permanent Recruitment company and the Employer of Choice for top performing Recruiters.

 For further information on this role please contact Hannah Doyle on 086 107 0950 Engineering@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/  

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

 

 

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