Title:  Sr. Manager - Engineering & Projects (API)

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

Experience: 10 to 15 yrs experience in API manufacturing plant in Engg. & Project dept

Job Profile

a) Quality:.  Engineering Quality System, Faced Regulatory Facility Audits

b) Budget : Preparation of annual Engineering Capex & Plant Modification costing to meet the site business Plan.

c) Strategic plan: 

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 train the department personnel by identifying the training needs.
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.
Propose annually a list of activities and Project Key Milestones (on the critical path) in line with the project plan.

Strong project management skills.

Must have basic knowledge of Electrical & Instrumentation.

d) Must have Exposure to: USFDA, EMEA, UK MHRA, ANVISA and other regulatory compliances, Monitoring, Operational Excellence, Audits and Compliance.

e) Continuous Improvement process: Maximize the resource utilization and flexibility while minimizing the energy, water & utility costs. Basic knowledge on Lean manufacturing System (Kaizen)

f) Performance plan and Follow-up: Develop Systems and processes to monitor and optimize  engineering resource utilization