The Quality Specialist provides direct Quality support to a production area as part of an Integrated Product Team. With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures quality and compliance of products manufactured by the functional area, adherence to GMP and represents quality on the shop floor. You will perform review of process documentation/data for accuracy, completeness, and data integrity compliance. The incumbent may support the completion of batch disposition activities for release of product and may assist in conducting investigation of deviations. Additionally, the Quality Specialist spends significant time on the shop floor in a team environment to provide quality coaching and guidance, to enable documentation to be completed right the first time, and to ensure compliance with cGMPs and regulatory requirements.
- 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
To apply contact Martin Lynch on 087-344 3581.
Email CVs to firstname.lastname@example.org
|Job Category||Quality Specialist|