QA Specialist (Shift days)
RK23461
Contract – 11 months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


This role involves The Quality Assurance Specialist to spend 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.


Duties:

• Provide direct Quality support to production and support areas.
• Provides presence on the shop floor to support compliance and data integrity.
• Review and approve GMP documentation/data for accuracy and completeness.
• Review and approve 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.
• QA support, review and approval of C&Q, Performance qualification (PQ) & Process Validation documents.
• Support sustaining activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance & Calibration Programs.
• 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.


Educational and Experience

• Bachelor degree, in a scientific or engineering field.
• 3 years of relevant post-degree experience in a GMP environment: manufacturing, laboratory, quality, operations, technical, or regulatory function.
• Shop floor manufacturing experience


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.