Quality Digital Systems Supervisor

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:

• Bachalor's degree in Pharmacy, Computer Science, Industrial Engineer or related field.
• Minimum 3 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).