Job Description
• Monitor compliance of Group quality systems and systems with quality impact against guidelines, Data Integrity, and CSV requirements.
• Contribute to Group-level policies and guidelines on quality digitalization.
• Conduct Gap Assessments and prepare Action Plans.
• Assist in designing and monitoring a stepwise Group digitalization plan for structured, goal-oriented transition.
• Contribute to URS preparation and validation planning.
• Support IT/IS during implementation, maintenance, and upgrades of systems.
• Contribute to Group-wide audit plan for quality-related software.
• Prepare compliance, risk, and corrective action reports.
• Deliver training programs on CSV, Data Integrity, and Quality Digital Systems.
• Promote awareness and acceptance of digital quality culture.
Requirements:
• Bachelor's degree in Pharmacy, Computer Science, Industrial Engineer or related field.
• Minimum 3–5 years of experience in pharmaceutical quality systems or CSV compliance.
• Familiarity with EQMS, LIMS, EBR, and similar systems.
• Strong knowledge of Annex 11, 21 CFR Part 11, and Data Integrity requirements.
• Ability to collaborate effectively with IT/IS teams and communicate with end users.
• Strong training and knowledge transfer capabilities
• Ability to conduct Gap Assessments and reporting.
• Proficiency in English (written and spoken).
