Project Lead

LYWO RECRUITMENT CONSULTING

Hyderabad

On-site

INR 900,000 - 1,600,000

Full time

14 days+
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Job summary

LYWO RECRUITMENT CONSULTING in Hyderabad, India seeks an experienced Project Manager to oversee planning, design, construction and commissioning of pharma facilities. The role ensures cGMP compliance and regulatory alignment across civil, structural and MEP work, with emphasis on quality and safety.

You will lead cross-functional teams, manage budgets and schedules, mitigate risks, and deliver audit-ready documentation and FAT/IQT/QC protocols as required.

Qualifications

  • Leadership of cross-functional teams across engineering, QA and operations.
  • Strong focus on cGMP and pharmaceutical regulatory alignment.
  • Budget control, schedule management and risk mitigation.

Responsibilities

  • Lead end-to-end project planning from design through commissioning.
  • Oversee civil, structural, MEP works and related installations.
  • Ensure site designs meet cGMP and regulatory standards from outset.
  • Direct cross-functional teams and report to senior stakeholders.
  • Maintain audit-ready C&Q records and risk assessments.

Job description

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.
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