Role & responsibilities:

1. 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.

2. 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.

3. 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.

4. 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)
🏢 LYWO RECRUITMENT CONSULTING
📍 Hyderabad