Job Description

• Regular co-ordination with US CFTs and to plan, navigate and delegate work distribution amongst team members.
• To train, monitor, build and align the team for procedure, system and timely support of services to US CFTs.
• To review and co-ordinate written documentation for all manufacturing activities. These documents include but are not limited to master batch records, SOPs, Change controls and other manufacturing related documentation etc.
• To review and co-ordinate Process/Cleaning validation/study assignments and projects which require sound pharmaceutical/engineering skills.
• To review and co-ordinate validation document activities such as FAT, IQ, OQ, PQ, Re qualification protocol, Revision in qualification documents, other documents for equipment/utilities/facilities for US sites. Also support extension for rest sites in world.
• Prepare regular reports on performance, progress, and issues for senior management and US CFT.
• Preparation of departmental budget and monitoring.
• Guide, motivate, and supervise team members to achieve individual and organizational goals.
• Set goals, develop plans to achieve them, and align team activities with overall company strategy.
• Monitor and evaluate employee performance, provide feedback, and implement improvement plans when needed.
• Identify issues, analyse them, and implement solutions effectively and efficiently.
• Serve as a bridge between upper management and staff, ensuring information flows smoothly in both directions.
• Identify training needs, help with career development, and foster a learning culture.
• Ensure the team follows company policies, legal requirements, and safety guidelines.
• Participate in recruiting, interviewing, and selecting new team members to build a strong workforce.
• Assign tasks to the right team members based on their skills and workload, ensuring efficient execution.
• Communicate with clients, vendors, or internal stakeholders to manage expectations and maintain strong relationships.
• Create a positive work environment by recognizing achievements, encouraging collaboration, and promoting morale.

Additional Responsibilities:

Education:

• Bachelors Degree (BA/BS) B.E. - Required

• Master Degree (MS/MA) ME - Preferred

Experience:

• 15 years or more in 15+ Years

Specialized Knowledge: Licenses: