Quality Control Specialist
2 weeks ago
Role: Quality Control Specialist
Contract Type: Fixed Term Contract - 11 Months
Work Location: Clonmel, Tipperary, Ireland
Client: A global healthcare company committed to advancing medical innovation and improving patient outcomes through science-led initiatives. It focuses on developing life-changing medicines, vaccines, and biologic therapies across various therapeutic areas, including oncology, infectious diseases, diabetes, vaccines, and animal health. With a mission to save and improve lives.
ABOUT THE ROLE
The Quality Assurance Specialist is an integral member of the Quality team, responsible for supporting the Good Manufacturing Practice (GMP) activities at the Ballydine site. This role ensures compliance with regulatory requirements and assists in maintaining the highest standards of quality assurance across all aspects of production. The Specialist will also be responsible for the release of incoming goods, products for which production or packaging is outsourced, and products and processes in full compliance with quality procedures, legal guidelines, quality guidelines, and market authorization. Responsible for advice on and improvements of quality-related issues, in order to ensure an optimal quality of released products and processes. Will understand the quality requirements for the introduction of materials to site, will have the capability to communicate the requirements to suppliers and will use good documentation practices and be capable of implementing these at a local level. Works with moderate work direction and is skilled and knowledgeable to the position.
Key Responsibilities:
- Review and approve production and analytical documentation accompanying the release of drug substances, drug products, and packaged finished goods, ensuring conformance with SOPs, GMP, and regulatory requirements, including supporting QP certification.
- Perform and review investigations of complaints, deviations, change controls, and CAPA (Corrective and Preventive Actions).
- Develop and maintain assigned Standard Operating Procedures (SOPs).
- Compile data for reports and presentations, interpret findings, and draw meaningful conclusions.
- Conduct audits to verify compliance with SOPs, GMPs, and relevant regulations.
- Support product recalls and stock recoveries as needed.
- Actively communicate and collaborate with cross-functional teams to foster strong relationships and a clear understanding of roles and responsibilities, leveraging these networks to address issues arising during audits and reviews.
- Identify compliance gaps and recommend continuous improvement actions.
- Assist with the induction of new employees and the training of existing staff.
- Adhere to standard procedures and seek guidance from the manager or supervisor for any exceptions.
- Execute all tasks with a commitment to compliance, efficiency, innovation, accuracy, and safety in accordance with company and regulatory standards.
- Stay up-to-date with cGMP requirements as outlined in applicable worldwide regulations.
- Represent the Quality Assurance department on cross-functional teams.
- Perform additional duties as assigned by the manager or supervisor.
ABOUT THE CANDIDATE
- A degree in a Science or Engineering discipline.
- Industrial experience.
- Excellent communication and organizational skills.
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