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QA Operations Shift Specialist
1 month ago
Join to apply for the QA Operations Shift Specialist role at TieTalent.
This is a shift role (4 x 12hr extended days followed by 4 days off).
AboutThe Quality Specialist provides direct Quality support to a production area as part of a Quality IPT (Integrated Product Team). With guidance from the Associate Director of Quality Operations, the Quality Specialist ensures product quality and compliance, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor. This role is based in Dublin within a leading biotech multinational.
Key Responsibilities- Review and approve new and updated Master Batch Records / Electronic Batch Records.
- Review and approve production documentation such as executed electronic batch records and logbooks to ensure accuracy and compliance with cGMPs and company procedures.
- Support compliance and data integrity on the shop floor.
- Review and approve new and updated SOPs/Work Instructions and Controlled Job Aides.
- Participate in the Tier process to identify issues and collaborate on resolutions.
- Support QA review and approval of commissioning and qualification lifecycle documents for capital projects and new equipment.
- Serve as the QA SME for Performance Qualification activities, including equipment, facility, utility PQ studies, cleaning validation, SIP, and process validation.
- Support sustaining activities such as Change Management, Deviations, CAPAs, Equipment Requalification, and periodic reviews.
- Assist with internal audits and regulatory inspections.
- Bachelor's degree in a scientific or engineering field (or relevant experience).
- Minimum 5 years of post-degree experience in GMP manufacturing, QA, or laboratory environments within the pharmaceutical or biotech industry.
- Experience with QA operations and regulatory engagement is an advantage.
- Strong leadership skills and excellent communication abilities.
- Knowledge of cGMPs and regulatory requirements.
- Interpersonal skills including flexibility, collaboration, and teamwork.
- Change Management experience.
Dublin, Ireland
Work Experience- QA
- English
Mid-Senior level
Employment TypeFull-time
Job Function- Quality Assurance
- Technology, Information and Internet
