Senior Quality Specialist
CareerWise Recruitment View all jobs
- Dublin
- Contract
- Full-time
- Support the Quality Manager and Qualified Person in maintaining compliance with Good Manufacturing Practice (GMP), for Medicinal Products, Quality Systems, local and corporate procedures, regulatory requirements, and industry standards.
- Assist the Quality Manager and Qualified Person in the development of continuous improvement and compliance projects within the Quality Department. For example - Support projects as the business expands within the compounding services division
- Review and co-ordinate any CAPA investigations for deviations at the site which may impact on product quality for products supplied to the client.
- Co-ordinate customer and supplier complaints - including investigations, reporting, and trending. Ensure the management of the SAP disposition of non-conforming products.
- Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with GMP and GDP.
- Prepare information in advance for presentation at the Quality Review Board meetings.
- Assist in the completion of internal audits of GMP systems, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken.
- Assist the Quality Manager in maintaining copies of the approved Specifications in the Document Management system and ensuring the relevant personnel are included in the distribution list
- Recording, investigating and reporting incidents and deviations to the Quality Manager and Qualified Person.
- Assisting Process Owners in assessing risks and assigning counteractive measures.
- Documenting and managing relevant change controls through to completion.
- Ensure the adherence to the stability schedule.
- Management of the stability data for the support of the expiry dates.
- Assist in the co-ordination and documentation of product recalls and mock recalls.
- Support Pharmacovigilance and Compliance activities as required.
- Responsible for issuing protocol and report numbers and maintaining associated logs.
- Bachelor’s degree or higher; ideally in a related Science discipline
- Demonstrated ability in quality systems support
- Knowledge of EU quality related pharmaceutical regulations
- Experience in compounding and working in a MIA environment
- Knowledge of Industry Best Practices for quality and compliance related topics
- SAP experience.
- The ideal candidate will have 3- 5 years’ experience in a pharmaceutical/regulated background GMP and regulatory expectations.