A Compliance Specialist is required by CareerWise Recruitment for our Limerick based client.
The Compliance Specialist, Drug Product Manufacturing is a member of the Drug Product Manufacturing Team and is responsible for operations support and compliance related activities.
Role of this position
- Lead and manage deviation investigations, CAPAs, and change controls.
- Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
- Responsible for generating and tracking performance metrics.
- Maintains knowledge of current good manufacturing practices cGMPs.
- Responsible for periodic reviews of Drug Product Manufacturing documentation and records to assess for compliance with established quality standards, policies and procedures.
- Assist in maintenance of product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers.
- Specialist; minimum of BS/BA in scientific discipline with 2+ years of related experience in cGMP manufacturing
- Knowledge of drug product manufacturing from formulation through the final package.
- Basic knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Experience in collaborating with CMOs/CROs is preferred.
Please call Lisa Casserly today for further information on 091-339136 or email: email@example.com
CareerWise Recruitment (In Search of Excellence)