Compliance Specialist - Pharmaceuticals, Tipperary
Client:
Morgan McKinley
Location:
Tipperary
Job Category:
Other
EU work permit required:
Yes
Job Reference:
f9d71218340b
Job Views:
83
Posted:
22.01.2025
Expiry Date:
08.03.2025
Job Description:
Job Description
An excellent opportunity to join a pharmaceutical company based in Tipperary as a compliance specialist in their growing team.
You will have a science or quality background with a minimum of 3 years' experience in a pharmaceutical manufacturing environment related to finished drug products. Knowledge of EU GMP, US FDA, and other related regulations is essential. Previous experience working in compliance related to drug products, combination devices, and/or sterile products is highly advantageous.
Compliance Specialist Responsibilities:
* Oversee Complaints & Quality Defect Reporting Systems
* Identify and communicate to Quality leadership issues that may impact product quality, safety, efficacy, regulatory compliance, or business continuity which have arisen from a supplier or other element of the role.
* Oversee Investigations, RCA, Quality Risk Management to ensure any such investigations are documented appropriately with relevant CAPA.
* Coordinate local regulatory activities.
* Coordinate the Supplier Quality Management System.
* Coordinate any site regulatory audit readiness programs.
* Support QP certification activities.
* Support the review and approval of Quality System & Compliance documents.
* Support and coordinate inspections.
* Update Quality Procedures and other documents to ensure current best practices.
* Support NPI/Technology Transfer projects as required.
* Prepare Annual Product Quality review reports.
* Support the Quality Management Review process by providing required KPI data.
* Lead projects including working as part of a multidisciplinary team as required.
* Contribute to the overall improvement of the company from a Quality, GMP, Compliance perspective.
For more information on this role or to apply, please contact me at 021 2300 300.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
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