A Compliance Specialist is required by CareerWise Recruitment for Limerick based biopharma company on a 12 month contract basis. The Compliance Specialist will lead investigations and root cause analysis for all Facilities Department issues of non-compliance and will act as a liaison between the Facilities Department and onsite quality and regulatory groups to define and address issues of non-compliance.
Role of this position
- Facilitates all reviews and revisions of all Facilities Department related SOP's, plans and policies for each group within the Department.
- You will provides support, information, and assistance to individual groups and supervisors with the initiation, review, submission, and follow-up of documents such as Change Controls, low impact investigations, (NOE's), medium to high (EOEs) and devaitions (DNF's), impact statements and corrective action plans (CAPA).
- You will provide tracking and trending for all facilities and maintenance related compliance activities i.e NOEs, EOEs, CAPAs and Change Controls.
- You will provide periodic review of the 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).
- 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.
- Minimum of 2+ years' experience working in a Compliance function in a cGMP environment.
- Excellent communication skills with the ability to engage with a diverse range of individuals across all levels of the organization.
- Strong Technical writing ability.
- Proficient in MS Office (Word, Excel, Outlook, Access and PowerPoint).
Please contact Michelle Galvin today for further information on 091 373938 / email@example.com
CareerWise Recruitment (In Search of Excellence)