Job Description

Job Purpose:

·       To plan, coordinate, and execute the establishment and commissioning of  pharmaceutical manufacturing facility, ensuring compliance with GMP, ISO, and regulatory  requirements, while meeting project timelines and budgets.

 

Key Responsibilities:

·       Project Planning & Coordination

·       Develop master project schedules and work breakdown structures (WBS).

·       Coordinate with architectural, HVAC, cleanroom, utility, and process equipment  vendors.

 

Execution & Monitoring

·       Supervise construction, equipment installation, qualification, and validation.

·       Ensure compliance with URS, cGMP, ISO 13485, and regulatory body expectations.

·       Stakeholder Management

·       Interface with consultants, contractors, internal teams, and government  authorities.

 

Quality & Safety Assurance

·       Ensure adherence to EHS standards and validation protocols.

·       Cost & Risk Management

·        Track project expenses, control cost overruns, and manage project risks.

 

Key Deliverables / KPIs:

·       On-time project completion

·       Budget adherence

·       GMP-compliant plant handover

·       Successful qualification and validation (DQ, IQ, OQ, PQ)

·       Minimal regulatory observations