A Quality Specialist is required to support the Quality Systems activities in both the Drug Substance and Drug Product facilities at a leading Biopharma facility in South Tipperary.
The Quality Specialist will provide leadership through knowledge and skill regarding the validation standards required for a Drug Substance and Drug Product (SDI & OSD) pharmaceutical facility.
Key Responsibilities
* Participate in and support the site PVC, WVC, CVG, and EQVC committees.
* Approve all validation documentation and ensure compliance with policies, procedures, and guidelines.
* Maintain validation status following changes/modifications.
* Support the implementation of site or capital projects by defining validation requirements and providing technical assistance and support.
* Develop Validation Summary Reports and assist in developing overall Quality plans for major projects.
* Work with other areas and industry to predict future trends in validation and determine best practice.
* SAP Quality Process Steward and Quality SME for Change Control.
* Principal Quality contact for all site change requests with impact on processing.
* Provide Quality and change analyst review for all change requests through all stages of the change control process.
* Principal Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.
* Laboratory QA oversight: Support and approve 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.
* Microbiology Point of Contact: Knowledge of microbial requirements in the pharmaceutical industry.
* Quality Agreement System Management: Manage the site inventory of Quality Agreements.
* Annual Review System Management: Manage the system ensuring Annual Reviews are completed to meet the schedule.
* Creation, review, and approval of Site Quality documentation.
* Quality Oversight of site application User Access Reviews.
* Participate in investigation and review of customer complaints.
* Filing & Licence maintenance and Regulatory Requests follow-ups.
* QA Regulatory Data: Review and verify documentation for regulatory submissions/filings.
* Returned Goods: Manage segregation and disposition of all returned goods.
* Audit program: Support internal GMP walk-down and scheduled audits program.
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.