Sr. Manager – Engineering & Projects (API)

• Responsible for Engineering Quality System, Handling Regulatory Facility Audits
• Preparation of annual Engineering Capex & Plant Modification costing to meet the site business plans
• Responsible to prepare SOPs and to suggest for corrective actions related to project management
• Responsible to prepare Qualification Protocol ( DQ, IQ, OQ & PQ).
• Responsible to participate in Self inspections.
• To ensure for the availability of critical spares/ consumables during the commissioning of New equipment’s.
• To ensure that Good Engineering Practices are implemented.
• To conduct vendor inspections as and when required.
• Responsible for imparting training to the personnel in Engineering Dept. SOPs related to their job roles.

• 10 to 15 yrs experience in API manufacturing plant in Engg. & Project dept
• Strong project management skills.
• Must have basic knowledge of Electrical & Instrumentation.
• Must have Exposure to: USFDA, EMEA, UK MHRA, ANVISA and other regulatory compliances, Monitoring, Operational Excellence, Audits and Compliance.
• Continuous Improvement process: Maximize the resource utilization and flexibility while minimizing the energy, water & utility costs. Basic knowledge on Lean manufacturing System (Kaizen)
• Performance plan and Follow-up: Develop Systems and processes to monitor and optimize  engineering resource utilization

B.E. / B.Tech. (Mechanical)