01Overview
Digital Quality, IT Project Quality Manager - LIMS
Location: Hyderabad
Be part of Lonzas world-class Quality and Regulatory team. As an IT Project Quality Manager specializing in Laboratory Information Management Systems (LIMS), you will be a key contributor to our Global Capability Center (GCC). You will be responsible for the qualification and validation compliance of computerized systems used for cGMP activities, driving the planning and timely execution of validation deliverables to ensure the highest standards of data integrity and regulatory compliance.
What you will get
- An agile career and dynamic working culture.
- An inclusive and ethical workplace.
- Compensation programs that recognize high performance.
- Global exposure and the prospect to work collaboratively across global regulatory and IT workstreams.
- Comprehensive benefits package including medical insurance and wellness programs.
What you will do
- Validation Planning: Create and maintain a comprehensive validation execution plan in alignment with project timelines, budgets, and Lonzas Quality Management System (QMS).
- LIMS & CSV Oversight: Lead the planning and timely execution of validation deliverables for LIMS and other computerized systems, ensuring all cGMP activities meet global compliance standards.
- Test Management: Take responsibility for the timely and compliant setup and execution of tests within Lonzas Test Management System (Kneat), monitoring progress from script creation through to final review.
- Project QA Leadership: Act as the voice of Quality in cross-functional teams, driving CSV strategy and standards across the Lonza global network during all project phases.
- Documentation & Approval: Review and approve technical documentation, risk assessments, CSV protocols, reports, test scripts, and deviations to ensure adherence to Lonza quality standards.
- Training & Advisory: Ensure project team members are trained according to Lonza IT requirements and advise teams on p .
