QA Operations Shift Specialist

The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have. This is a shift role (4 x 12hr extended days followed by 4 days off). The 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 quality and compliance of products manufactured by the functional area, adherence to Good Manufacturing and Documentation Practices, and represents quality on the shop floor. This is a Dublin based role within a leading Biotech multinational.

Key Responsibilities

• Responsible for review/approval of 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.
• Provides presence on the shop floor to support compliance and data integrity.
• Review and approve new and updated SOPs/ Work Instructions and Controlled Job Aides.
• Actively participates in the Tier process and uses this forum to make issues 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.

Required

• Bachelor degree, in a scientific or engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.
• Minimum 5 years of relevant post-degree work experience in GMP Manufacturing, Quality Assurance or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or laboratory operations.
• This role requires a seasoned professional with the expertise with at least 5 years working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
• Evidence of leadership skills coupled with good oral and written communication skills.
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
• Demonstrated interpersonal skills including flexibility, collaboration and inclusion skills and ability to work in a team environment.