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May 26 2018

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Job Opportunity: Compliance Specialist:

Job description:

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Compliance Specialist

function Description


The position coordinates cGMP compliance for the Raheen Facilities Department.

Essential tasks and Responsibilities include, but are not limited to, the following:
   » Lead investigations and root cause analysis for all Facilities Department issues of non-compliance.
   » Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.
   » Facilitates all reviews and revisions of all Facilities Department related SOP's, plans and policies for each group within the Department.
   » Provides support, information, and assistance to individual groups and managers with the initiation, review, submission, and follow-up of documents such as Change Controls, NOE's and DNF's, impact statements and corrective action plans.
   » Provides tracking and trending for all facilities and maintenance related compliance activities i.e NOEs, EOEs, CAPAs and Change Controls.
   » Provide periodic review of Facilities Department documentation and records such as logbooks, preventative maintenance records and work orders to assess for compliance with established quality standards, policies and procedures.
   » Participate in and obtain results of all Facilities Department quality and regulatory audits.
   » Coordinate training for Facilities personnel on regulatory and quality topics such as proper documentation procedures and the use of QUMAS.
   » Follows current good manufacturing practices (cGMPs).

Education and practice:
   » BS/BA in engineering or scientific related field with 3+ years of related professional practice in a cGMP environment or in the operation of an industrial facility.
   » Minimum of 2+ years practice working in a Compliance function in a cGMP environment.
   » Excellent communication expertise with the capability to engage with a diverse range of individuals across all levels of the organization.
   » Strong Technical writing capability.
   » Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint).

Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Limerick City
Company Type Employer
Post Date: 05/15/2018 / Viewed 24 times
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