Site Production Head (API Manufacturing)

Job Responsibilities:

• To oversee all activities from technical absorption of a process for a clinical or a developmental molecule to mapping equipment for scale up trials, validation and commercial scale up manufacturing of the product for an innovator or a generic company respectively.
• To interact with a team of delivery managers and project managers for ensuring smooth progress from initiation to completion of intermediates/API, with a focus on avoiding cost and time overruns.
• Ensuring current SOPs are available for all Production activities.
• Ensure that facility, equipment are maintained as per SOP.
• To ensure the operator is operating the equipment safely by following Safety guidelines and wearing the PPE during the execution of production activities in the concerned block.
• To ensure, efficient (in terms of cost and quality) and timely absorption of new absorption of new technologies in order to improve product offering as per area objectives.
• Ensure investigating product Incidents, OOT & OOS and taking necessary correction, corrective action and preventive action.
• Ensure investigating pertaining to market complaints, recall investigations, return good investigations, incidents are performed as per respective SOPs with right Root Cause analysis and proper investigation reports, take necessary correction, corrective action and preventive action.
• Ensuring that the production facilities are clean and maintaining high standards of housekeeping.
• Implement changes in-process, equipment and procedures.
• Ensure qualification of the new / modified facilities and equipment before use.
• To complete the trainings in Learning Management System (LMS) and ensure respective team members are completed their trainings in LMS.
• Training all personnel on cGMP, Safety and production related activities.
• Production planning ensures that the batches are produced as per plan.

Qualifications:

B.Tech - Chemical Engineering with 20+ years of experience