Deputy General Manager / General Manager - Projects
Qualification : Mechanical Engineering graduate – B Tech
Work Experience : 18 -20 years in regulatory pharma companies
Desired experience :
- Working experience in pharmaceutical OSD / sterile Injectable ( formulation / fill finish ) plant
- Hands on experience in building facilities following USFDA / EU cGMP guidelines
- Experience of handling automated control systems with 21 CFR part 11 compliance, integrating individual systems on central servers, Manufacturing Execution system
- Experience of interacting with consultants and coordination with other departments – Engineering / Manufacturing / Quality / Finance / Regulatory
- Macro & micro planning of project activities through Gantt chart
- Handling of contractors at site and site supervision ability
- Cost estimation for project
Desired Knowledge :
Sound knowledge of mechanical engineering with understanding of sterile injectable / pharmaceutical machineryHandling of international technology vendors and grasp of new ideasClean systems - water system, purified water system, WFI system, clean steam generatorJob Description :
To evaluate the project feasibility / provide project costDesign and detailed engineering of the project – along with architects and design consultantsCreate execution plan for the project : identification the project consultants / contractors / vendors for executing a project designed for specified capacity / purpose / quality / URS,Mobilizing and allocating project manpowerTo co-ordinate with consultants, vendors, contractors at site for timely and quality deliverableEnsure construction safety during project executionTo demonstrate the plant performance and smooth handover to userTo ensure completion of documentation in time, capitalization of project within stipulated timeDevelopment & Training of project team to impart skills in project management, engineering techniques, GMP designs, safety in construction for effective execution of projects,To negotiate technically and commercially with vendorsThe main goal is to complete the project with quality parameters and within the allocated budget and time schedule. Budget monitoring of the project is one of the responsibilities of the candidate.Job KRAs / Expectations :
To propose alternatives considering company's growth plans, analyze various options techno-commercially, determine appropriate technology optionsTimely completion of project within approved budget with zero LTABench marking the design with industry w.r.t. Energy, safety and futuristic plantCompliance to statutory bodiesSmooth co-ordination with external agencies – architects, consultants, contractors, vendors & internal usersGMP compliant facility execution - envisioning long term regulatory expectationsSmooth handover of the plant to user by imparting the training as required for the operations & engineering teamEscalation of critical issues to senior management on timeTravel to project sites / existing plants is a necessity of the job role.
Skills Required
Project Management, Mechanical Engineering, Cost Estimation, Manufacturing Execution System