Project Lead - Greenfield API Manufacturing Facility

Job Location: Initial 3 to 4 months in Hyderabad (Telangana), followed by relocation to Solapur (Maharashtra)

We seek a seasoned Project Lead to spearhead the planning, design, and execution of our greenfield API manufacturing facility in Sholapur. This role demands expertise in overseeing all project aspects, from civil construction to equipment installation. You'll ensure timely completion within budget while adhering to regulatory standards. A deep understanding of pharmaceutical facility construction and project management is crucial, as is the ability to lead cross-functional teams.

Roles & Responsibilities:

Project Planning & Design

1. Lead the development and execution of a comprehensive project plan for the greenfield API manufacturing facility, encompassing all phases from initial design to commissioning and qualification.
2. Define project scope, objectives, and deliverables in alignment with business goals and regulatory requirements.
3. Oversee the preparation of detailed engineering designs, drawings, and specifications for civil, structural, MEP (Mechanical, Electrical, and Plumbing), and process equipment.
4. Ensure compliance with cGMP (current Good Manufacturing Practice) guidelines and other relevant pharmaceutical regulations throughout the design and planning phases.
5. Develop URS (User Requirement Specifications) and FAT (Factory Acceptance Testing) protocols.

Construction & Execution

1. Ensure all construction activities comply with safety regulations and environmental guidelines.
2. Monitor project progress, identify potential delays or risks, and implement corrective actions to maintain the project schedule and budget.
3. Implement rigorous quality control measures to ensure adherence to design specifications and regulatory standards.
4. Oversee vendor selection, procurement, and contract management for all construction-related activities.
5. Manage the construction of the API manufacturing facility, including civil works, structural erection, and installation of MEP systems and process equipment.

Commissioning & Qualification

1. Ensure all C&Q documentation is complete, accurate, and compliant with regulatory standards.
2. Manage the validation process for critical manufacturing processes and analytical methods.
3. Prepare and review qualification protocols (IQ, OQ, PQ) to ensure that equipment and systems meet specified performance criteria and regulatory requirements.
4. Develop and execute commissioning protocols, including SAT (Site Acceptance Testing) and performance testing.
5. Lead the commissioning and qualification (C&Q) activities for all equipment and systems in the API manufacturing facility.

Project Management & Compliance

1. Prepare and present project status reports to senior management and stakeholders.
2. Ensure compliance with all applicable regulatory requirements, including cGMP, environmental regulations, and safety standards.
3. Lead cross-functional teams comprising engineering, operations, quality, and regulatory personnel.
4. Conduct risk assessments and implement mitigation strategies to minimize potential disruptions to the project.
5. Manage the project budget, track expenses, and control costs to ensure the project is completed within budget.
6. Conduct HAZOP (Hazard and Operability) studies.