Production Manager

- Production Planning and conduction of daily meetings.

- Review of BMR, BPR, logbooks, monitoring of daily activities on shop floor.

- QMS activities related to production department.

- Co-ordination with engineering department to save the utilities based on the requirement.

- To allocate the manpower to the respective area to ensure that the manpower is utilized effectively.

- To investigate on deviation related to process, product, and equipment.

- Review of periodic validation activities of the Production department.

- To ensures the health and safety of the Employees during working in the area.

- To ensure the effective participation of all employees in activities conducted by the company.

- To ensure that all Packing and manufacturing activities are carried out consistent with the GMP requirements.

- Coordination with QA related to quality system related issues. (Deviation, change control, CAPA, OOS, Investigations).

- To ensure adherence to proper status labeling, segregation and strict in process control.

- To ensure appropriate process/packing validation and calibration of equipment are performed and record and report made available.

- To implement Quality risk management and risk management controls with the level of risk and evaluating the result of risk management efforts.

- To review plant and equipment preventive maintenance programs and to authorize Job work order in case of preventive /breakdown or maintenance activity.

- Explain the infrastructure and maintenance of production department to the regulatory agency / auditors and whereby any observations shall be responded in association with QA.

- On Job training of Production employees as and when required.

- Selection of employees for production department as per procedure.

- Making weekly/ monthly production schedule in liaise with cross functional team.

- Ensure all the equipment are well maintained and proper preventive maintenance carried out.

- Ensure manufacturing activities carried out with on line completion of records and logs.

- Review of executed as well as master documents.

- Master documents authorization..

- To review and authorize equipment qualification protocol and reports.

- Approval of Cleaning validation protocol and report.

- Management reporting on production activities.

Responsible for safety assurance in production department.

Functional Competencies

1. Thorough Knowledge of cGMP.

2. Awareness of Regulatory Guidelines & Requirements pertaining to GMP.

3. Documentation & Reporting.

Behavioural Competencies

1. Team work.

2. Attention of details.

3. Execution excellence.

4. Communication skills.