- Responsible for meeting production targets as per requirements of marketing and prepares production plans accordingly.
- Responsible for safe handling and smooth functioning of production activities.
- Follows the instructions given by Head - Manufacturing and guides the personnel working under him to achieve the desired quality & quantity.
- Responsible for preparing, reviewing, approving, and distributing the instructions to produce intermediates or API's according to written procedures.
- Responsible for production of API's and intermediates according to pre-approved instructions.
- Plans to arrange resources as per the production plan / dispatches.
- Review of the batch manufacturing sheets, SOPs, Protocols and records.
- Ensure that validation protocols and reports are reviewed from time to time.
- Evaluating proposed changes in product, process, or equipment are in line with the current requirements.
- Making sure that new and when appropriate, modified facilities and equipment are qualified.
- Making sure that production-related complaints are investigated and resolved.
- Make sure to maintain the production plan as per the commercial schedules.
- Participating in internal audits / self-inspection programs and ensures the compliance.
- Ensuring scheduled maintenance, calibration and qualification activities are being carried out for production equipment.
- Identification of training requirements for shop floor personnel and ensuring the compliance.
- Responsible for implementation of CGMP requirements for the production of quality products in co-ordination with other departments.
- Responsible for implementation of the modifications and expansion programs designed by the management.
- Completion of all assigned trainings within the stipulated time frame.
- Ensuring appropriate material management at shop floor area.
- Ensuring the facility management and resource management as appropriate to the GMP requirement.
- In absence of duties, authorized Deputy is responsible for the above activities.
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