The incumbent will be responsible for
1. To oversee the overall Production/Plant functions.
2. Leading projects and project management
3. Hiring and training of plant personnel
4. Leading validation, qualification and documentation in compliance with applicable policies and guidelines
5. Supervising plant operations, plant quality requirements and safety
6. Coordination with planning, logistics and quality
7. Reporting for local statutory requirements, management and controlling
8. To design and implement the Production systems and procedures as per the USFDA requirements (Primarily, the ICH Q7A guidelines).
B.E.-Chem from IIT or Premium institute with about 15 yrs experience about 10 15 years of experience in API manufacturing companies of repute preferably MNC s in similar responsibility.
The person should have knowledge of chemical plant operations, fundamentals of process chemistry and basics of finance such as costing, budgeting and variance reporting.
Ability to communicate effectively in an international environment is required.
The person should have excellent people and leadership skills.
Knowledge of quality systems as required by regulatory authorities such as US FDA and of EHS requirements.