Role & responsibilities:
Planning & Design
Strategic Roadmap: Lead the end-to-end project plan from initial design through commissioning, aligning with business goals.
Technical Specifications: Oversee detailed engineering (Civil, Structural, MEP) and develop URS and FAT protocols.
Regulatory Alignment: Ensure all designs meet cGMP and pharmaceutical regulatory standards from the outset.
Construction & Execution
Project Oversight: Manage civil works, structural erection, and MEP/process equipment installation.
Operational Control: Monitor schedules and budgets, implementing corrective actions to mitigate risks or delays.
Compliance & Safety: Enforce rigorous quality control and safety standards across all construction activities and vendor management.
Commissioning & Qualification (C&Q;)
Validation Lifecycle: Lead C&Q; activities,



including the preparation and execution of SAT, IQ, OQ, and PQ protocols.
Process Integrity: Validate critical manufacturing processes and analytical methods to ensure equipment meets performance criteria.
Documentation: Maintain comprehensive, audit-ready C&Q; records compliant with regulatory expectations.
Management & Compliance
Leadership: Direct cross-functional teams (Engineering, QA, Operations) and report status to senior stakeholders.
Financial & Risk Management: Control project budgets and conduct HAZOP studies and risk assessments to ensure safety and continuity.
General Governance: Guarantee total adherence to cGMP, environmental, and safety regulations.

📌 Project Lead Hyderabad (India)
🏢 LYWO RECRUITMENT CONSULTING
📍 India