Job Description
An excellent opportunity to work with a pharmaceutical company based in Tipperary as a compliance specialist in their growing team.
You will have a science or quality background with at least 3 years' experience in a pharmaceutical manufacturing environment related to finished drug product. 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 are 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 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.