PMO - Formulations - Project Head

Role & responsibilities

• Projects

• Senior, technically qualified, hard core Pharma experienced professional , responsible for high standards deliveries in the areas of Engineering, utilities, infrastructure, Projects in the entire spectrum of high end pharmaceutical manufacturing business.

• Qualified Engineer & Management professional with B.Tech / M Tech , Mechanical/ Electrical qualification

• Have an extensive experience in Green field/Brown field project activities in Pharmaceutical industry both in Formulations & Biotechnology , API industry experience is an added advantage

• -To take on planning in sizing the plant, Implementation of plan from concept to commissioning

• • Design to meet the Statutory & Regulatory guidelines,

• -Effective implementation of challenging tasks, where processes and ideas are converted in to design , Safety, cGMP & capacity

• Capacity & Performance optimization skills of useful for brown field projects design, detailing, validation

Preferred candidate profile

• With 15-18 years of experience in Projects, in different positions with vide responsibilities in Formulation Units, and Green field projects of Formulation OSD ,Topical ,Soft gel, Injectables, of potent / non potent products with Bio Technology experience is an added advantage
• As Infra Project lead involved in Concept notes, with master plan preparations, Infra expansions plans for manufacturing of Formulations , then to Basic, Detailed Engineering, Procurement Planning , Execution and subsequent Qualifications/ Validation activities in both Formulations in general . Hands on experience in implementation of
• Familiar with Aseptic Filling / Terminally Sterilized vial filling equipment and Isolation / RABS of the M/C
• Familiar with Biologic API product Mfg Project
• Familiar with EduRox guidelines with ISO 14644 standard for clean room designs
• Handled good size of team in Green field Project execution
• Familiar with Safety practices in construction and Operational safety
• Familiar with Statutory, Schedule-M requirements in Projects function
• Familiar with Oncology , Harmon, Potent, Steroid requirements in design and execution
• The Contained facility experience in Solid Oral Dosage ( SOD) facility , Injectable facilities
• Constructing and commissioning of Biologic Manufacturing unit with complete DCS system
• R&D center with Animal house ,housed Formulation development lab , and Analytical R&D Center for development of Bioequivalence testing center and development of generic OSD drugs
• Construction of Ware houses with AS/RS,
• Involved in concept note development, FEED , Basic engineering , Detailed Engineering, VMP of facility , and Qualification activities of Manufacturing facilities
• Concept development and Basic design with consultant
• Detailed Engineering of facility
• Actively involved in Procurement process of all packages
• Land development work ,Integrating to Master plan of entire site
• All Statutory approvals for project like CFE, Factory license , Mfg Drug license, CEIG etc..
• Cost estimations & tracking of expenses Budget Vs actual + commitments at WBS level Formulation Project
• Coordinating for validation of processes & Qualification of facilities & Equipment activities to Validation team
• Building the team , for project & then in operations Involved in concept note development, FEED , Basic engineering , Detailed Engineering, VMP of facility , and Qualification activities of Manufacturing facilities
• Power distribution system 11/33 /122KV transformer yard to suit as per the statutory norms / erection & commissioning of 33KV Transformer yard
• Develop and review technical document, URS , P&ID, FAT, SAT and other specification document and obtaining Client approval
• Plan, participate and execute the equipment start up, commissioning, qualification and validation activities.
• Coordinate & interact with internal / external consultants and contractors for mechanical installations work
• Provide recommendations & contribute on equipment design , code compliance, operational ease & maintainability
• Contribute and participate for preparation and execution of GMP activities (DQ, IQ, OQ , and preparation of SOP etc.).