Quality Assurance Systems Specialist

• Support commissioning, qualification, and computer system validation projects.
• Write, execute, review, and approve validation protocols, reports, and lifecycle documents.
• Collaborate with IT, QC, Automation, QA, and vendors for qualification and validation activities.
• Perform change assessments and risk assessments.
• Act as SME for validation strategy for equipment, systems, computers, and methods.
• Troubleshoot systems and support staff training.
• Participate in client and regulatory inspections.
• Assist with investigations, root cause analysis, and CAPAs.
• Promote Data Integrity culture and raise DI awareness across the site.
• Improve DI maturity as defined by site/global standards.
• Establish and facilitate DI forum with structured agenda:
• Ongoing DI activities (remediation CAPAs, trainings)
• Sharing best practices and updates from Global
• Sharing site-level DI cases, deviations, and learnings
• Ad‐hoc topics (inspection preparation, etc.)
• Conduct regular DI GEMBA walkthroughs.
• Generate, review, and approve controlled documents and records.
• Supervise validation activities and advise on problem resolution.
• Make decisions related to commissioning, qualification, and validation.
• Work with stakeholders to resolve DI risks and gaps.

Experience:

• Minimum 5 years experience in pharmaceutical/biotechnology or related industry.
• Minimum 2 years experience in a Quality Unit.
• Experience with equipment & analytical instrument qualification.
• Experience with computerized systems validation.
• Working knowledge of GxPs, 21 CFR Part 11, Annex 11, and USP standards.

Education:

• Bachelor's Degree in Science (minimum).