QA Specialist
- Dublin
- Contract
- Full-time
A QA Specialist is required for a pharmaceutical company in Dublin. The successful candidate will hold primary batch release responsibility and ensure that all products managed by External Quality Assurance are manufactured, packaged, tested, released, stored and distributed in full compliance with regulatory requirements. They will maintain robust Quality Systems and oversee External Partners' manufacture and release of vaccine drug substances and products in line with all relevant regulations, policies and guidelines. This is a six months maternity cover role offered on a fully remote basis.Responsibilities:
- Evaluate and/or release products to other sites and/or to the market with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.
- Review and approve change controls.
- Manage routine and complex deviations and complaints and assist in the coordination of significant investigations.
- Conduct routine and solve complex analytical change requests and support process modification change controls.
- Stability Program management, including review of stability reports, and Annual Product Review assembly.
- Provide on-site guidance in the preparation of metrics, procedures, and guidelines.
- Track and monitor operational and quality performance of the EP/ExP and can work with supplier to develop Corrective and preventive action (CAPA) plans.
- Assist the maintenance of retention samples, ship reagents and samples to support licensure and foreign registration.
- Responsible for shipment under quarantine.
- Support routine process validation; review and approve validation reports/tech transfer
- Prepare pre-PAI assessments, support document requests for regulatory filings and post approval changes.
- Bachelor’s or Master’s degree in a Science, Engineering, or related area of study.
- 3 years' experience in the pharmaceutical industry with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control including global GMP Quality Systems and regulatory requirements.
- Batch release experience.
- Experience with manufacturing operations and/or analytical expertise associated with biologics and/or vaccines. Aseptic manufacturing experience preferred.
- Experience with qualification of manufacturing facilities/equipment (i.e. Process/Cleaning Validation, IQ/OQ/PQ) is preferred.
- Competency in Analytical Method Validation/Verification/Transfer and Analytical Standards is preferred.
- Quality Risk Management (QRM) Experience is preferred.