LSC require a Compliance Specialist to provides cGMP facilities compliance for our biotech client based in Limerick.
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 email@example.com for full details on this role or apply directly through this advert.