Project Manager - Pharmaceutical Laboratory systems

Role: Project Manager - Pharmaceutical Laboratory systems

Experience: 10-15 years

Notice Period: Immediate to 15 days

Location: PAN India

Shift timings: 2PM to 11PM

Job Summary:

The role involves managing pharmaceutical laboratory systems from an IT perspective, ensuring compliance with customer SOPs and regulatory requirements. The candidate will be responsible for incident management, change management (ITCR), deviations, CAPA processes, and end-to-end monitoring through closure while collaborating with crossfunctional stakeholders.

Key Responsibilities:

• Manage and support pharmaceutical laboratory systems from an IT and project management perspective.
• Utilize project management tools to plan, track, and deliver lab IT initiatives effectively.
• Handle incidents related to laboratory systems, ensuring timely investigation, resolution, and documentation.
• Raise IT Change Requests (ITCRs) with:
• Proper change description
• Justification and reason for change
• Impact assessment
• Implementation and rollback plans
• Documentation as per customer SOPs
• Monitor ITCRs through approval, implementation, and closure.
• Raise and manage deviations, including:
• Investigation and causal analysis
• Implementation of corrective actions
• Effectiveness checks and closure
• Compliance with customer SOPs
• Initiate and manage IT CAPA processes, including:
• Root cause analysis
• Action planning and execution
• Documentation and approvals
• Monitor deviations and CAPAs for:
• Extensions and amendments
• Approval workflows
• Timely and compliant closure
• Ensure adherence to GxP, data integrity, and regulatory requirements.
• Coordinate with business, quality, and IT stakeholders to ensure smooth operations and compliance.

Required Skills & Knowledge:

• Strong knowledge of Pharmaceutical Laboratory systems (e.g., LIMS, CDS, ELN preferred).
• Solid understanding of IT Change Management, Incident Management, Deviations, and CAPA.
• Experience working in regulated pharmaceutical or life sciences environments.
• Familiarity with customer SOPs, quality systems, and audit readiness.
• Strong documentation, analytical, and stakeholder management skills.
• Excellent communication and problemsolving abilities.