QA Operations Specialist (Shift)

QA Operations Specialist (Shift)
RK23044
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 performing review of process documentation/data for accuracy, completeness, and data integrity compliance. May also 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 first time, and to ensure compliance with cGMPs and regulatory requirements.


Duties:

• 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
• Participates as the quality member on cross functional projects
• 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
• Drive continuous improvement and utilise problem solving tools Participate in continuous improvement initiatives to enhance operational efficiency and resolve issues


Educational and Experience

• Bachelor degree, in a scientific or engineering field
• 5 years experience in GMP Manufacturing and working knowledge in the biotech industry with specific understanding of QA operations an advantage as well as Regulatory agency engagement.
• Understanding of cGMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area
• Experience with Quality systems, pharmaceutical manufacturing or laboratory processes, authoring and approving GMP documents

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