Job Description
An excellent opportunity to work with a pharmaceutical company in Tipperary as a compliance specialist.
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
* Identifying and communicating 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.
* Overseeing Investigations, RCA, Quality Risk Management to ensure any such investigations are documented appropriately with relevant CAPA.
* Coordinating of local regulatory activities.
* Coordinating of the Supplier Quality Management System.
* Coordinating any site regulatory audit readiness programs.
* Supporting QP certification activities.
* Supporting the review and approval of Quality System & Compliance documents.
* Supporting and coordinating inspections.
* Updating Quality Procedures and other documents to ensure current best practices.
* Supporting NPI/Technology Transfer projects as required.
* Preparing Annual Product Quality review reports.
* Supporting the Quality Management Review process by providing required KPI data.
* Leading projects including working as part of a multidisciplinary team as required.
* Contributing to the overall improvement of the company from a Quality, GMP, Compliance perspective.