Quality Specialist
PSC Biotech
- Dublin
- Permanent
- Full-time
- Participates as the quality member on cross functional projects.
- Responsible for review/approval of new and updated Master Batch Records / Electronic Batch Records
- Reviews executed production documentation such as electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures and ensures completion of proper remediation of errors.
- Provides presence on the shop floor to support compliance and data integrity.
- Review & approve new and updated SOPs/ Work Instructions and Controlled Job Aides
- Actively participates in the Tier process and use this forum to make concerns visible and to partner with the functional area on resolution.
- QA support, review and approval of Commissioning and Qualification lifecycle documents for capital projects and new equipment.
- Will serve as the Quality SME for Performance qualification (PQ) activities across the site including but not limited to: Equipment, Facility and Utility PQ studies, Cleaning Validation, SIP, process validation, Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification and Periodic review, Site Maintenance & Calibration Program.
- Provides support to internal audits and regulatory inspections.
- Collaborates with cross-functional team members in the identification and implementation of continuous improvement initiatives and action plans.