Facilities Compliance Specialist

Posted on: 18/05/2017
Ref: VAC-15584
 
  • Country: Ireland
  • Location: Limerick
  • Industry: Quality Assurance
  • Discipline: Quality Assurance
  • Employment Type: Contract
  • Duration: 52 weeks+

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Job Description

LSC require a Compliance Specialist to provides cGMP facilities compliance for our biotech client based in Limerick.

Your responsiblities:
o Lead investigations and root cause analysis for all Facilities Department issues of non-compliance.
o Acts as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address all issues of non-compliance.
o Facilitates all reviews and revisions of all Facilities Department related SOP’s, plans and policies for each group within the Department.
o Provides support, information, and assistance to individual groups and supervisors 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.
o Provides tracking and trending for all facilities and maintenance related compliance activities i.e NOEs, EOEs, CAPAs and Change Controls.
.
You will have:
o BS/BA in engineering or scientific related field with 3+ years of related professional experience in a cGMP environment or in the operation of an industrial facility.
o Minimum of 2+ years experience working in a Compliance function in a cGMP environment.
o Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization.
o Strong Technical writing ability.

Please contact Kathy on 021 45777329 or kgillen@lsc.ie for full details on this role or apply directly through this advert.

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