Job Title
A Compliance Specialist is needed to support the introduction of new products into our pharmaceutical facility in Ireland.
Responsibilities
* To ensure compliance with regulatory requirements and policies during product manufacturing.
* Maintain the integration of new products into our quality system.
* Support product transfers from development to commercialization, collaborating closely with cross-functional teams to address quality concerns and mitigate potential risks.
* Evaluate and approve vendors, manage technical agreements, and review analytical test method transfers.
* Collaborate with QA, R&D, and other functional groups to maintain roles and responsibilities, identify quality issues, and provide input on quality concerns.
* Coordinate site reviews of material specification documents, including in-process, BDS, drug product, raw material, and excipient specifications.
Requirements
* A third-level qualification in a science, quality, or relevant discipline.
* A minimum of three years' experience in a quality role supporting new product introductions.
* Strong knowledge of regulatory requirements and a background in quality and new product introduction.
* Experience gained within an aseptic processing environment, preferably within a quality function.
* Strong interpersonal and decision-making skills, with experience leading projects.
* A high level of attention to detail and mental concentration to ensure accuracy and total compliance with Quality procedures at all times.