Quality Assurance Specialist

Quality Assurance Specialist
Onsite
RK26197
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.



Key Responsibilities:

• 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 Commissioning and Qualification lifecycle documents for capital projects and new equipment.
• QA support, review, and approval for Performance qualification (PQ) & Process Validation activities across site.
• Support sustaining and QC activities such as change management, deviations, CAPAs, equipment requalification, periodic review, site maintenance and 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

• Bachelor’s 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.
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
• Leadership skills coupled with good oral and written communication skills.
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work/ upskill/coach a team environment.