QA

Quality Systems & Compliance

• Ensure compliance of manufacturing and analytical activities with GMP regulations, corporate procedures, and industry standards.
• Support the maintenance and continuous improvement of the Quality Management System (QMS).
• Contribute to audit readiness and support internal and external inspections.
• Participate in investigations, deviations, CAPAs, and quality risk assessments.
• Monitor quality and compliance KPIs and drive actions to improve performance.

Data Integrity Oversight

• Support the execution of the site's Data Integrity strategy and roadmap.
• Ensure compliance with ALCOA+ principles for both electronic and paper-based records.
• Develop, review, and deploy procedures and guidance related to Data Integrity.
• Act as the local Data Integrity SME and provide operational support to manufacturing teams.
• Review Data Integrity-related events and support investigations.
• Promote sustainable Data Integrity practices throughout the organization.

Shopfloor Support & Operational Oversight

• Maintain a strong presence in manufacturing areas.
• Conduct Gemba walks and routine spot checks on systems, audit trails, and documentation practices.
• Serve as the primary point of contact for operators regarding Data Integrity questions and concerns.
• Identify potential compliance risks and proactively drive corrective actions.
• Collaborate closely with Production, Quality Control, Engineering, Validation, and IT teams.

Continuous Improvement & Digitalization

• Identify opportunities to strengthen compliance, operational efficiency, and data reliability.
• Support digital transformation initiatives by ensuring Data Integrity requirements are integrated throughout project lifecycles.
• Lead or contribute to continuous improvement projects focused on quality performance and risk reduction.
• Drive best practices and lessons learned across the organization.

Training & Culture

• Deliver Data Integrity awareness and training sessions.
• Foster a strong culture of quality, accountability, and compliance.
• Coach and support employees in the application of GMP and Data Integrity requirements.
• Promote continuous learning and knowledge sharing within the organization

Education

• Bachelor's or Master's degree in Computer Science, Information Technology, Life Sciences, Engineering, Quality Management, or a related field.
• Equivalent experience in a GMP-regulated manufacturing environment may be considered.

Experience

• Experience in Quality Assurance within pharmaceutical, biotechnology, or regulated manufacturing environments.
• Proven experience in Data Integrity, Computer System Validation (CSV), or Quality Systems oversight.
• Experience supporting audits, inspections, deviations, CAPAs, and quality investigations.
• Experience working in cross-functional and operational environments.

Technical Knowledge

• Strong understanding of GMP/GxP requirements.
• Knowledge of Data Integrity principles and ALCOA+ expectations.
• Familiarity with FDA, EMA, EudraLex, PIC/S, WHO, and ICH guidelines.
• Understanding of computerized systems, audit trails, electronic records, and validation requirements.
• Knowledge of digitalization and automation projects is an asset.

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