Job Description
Quality Specialist
The Quality Specialist will play a crucial role in supporting the Quality Systems activities in both the Drug Substance and Drug Product facilities at our Biopharma facility in South Tipperary.
Main Responsibilities:
* Participate as a member of the Quality Systems Team and provide leadership through knowledge and skill regarding validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
* Approval of all validation documentation and ensuring compliance to policies, procedures and guidelines.
* Ensure that validation status is maintained following changes/modifications.
* Support the implementation of site or capital projects by defining validation requirements and providing technical assistance and support as a member of the project teams.
* Develops Validation Summary Reports and assist in developing overall Quality plans for major projects.
Additional Responsibilities:
* Works with other areas and industry to predict future trends in validation and to determine best practice.
* SAP Quality Process Steward Quality SME for Change Control.
* Principle Quality contact for all site change requests (with impact on processing).
* Provide Quality and change analyst review for all change requests through all the stages of the change control process ensuring compliance with site policies, procedures and guidelines.
* Principle Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.
Lab QA Oversight:
* Support and approve the systems supporting laboratory functions, instrumentation and GLIMS.
* Provide Quality oversight and approval for laboratory incidents / investigations and documentation.
* Stability oversight: Review and approval of stability reports (Intermediate and API stability data and reports are reviewed for accuracy and to support OOS and investigations as appropriate).
Quality Agreement System Management:
* Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships.
* Interact and communicate with SD&PM, relevant stakeholders and external parties to ensure appropriate Quality Agreements are current, approved, on file and retrievable.
Annual Review System Management:
* Manage the system ensuring that Annual Reviews (AR/APR/PQR) for products and systems incl automation, are completed to meet the Annual Review schedule.
Qualifications & Education:
* Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field.
* At least 1-2 years experience in the pharmaceutical industry.