Department: Production & Plant Head

Qualification: B. Pharm, M.Pharm

Experience: 23 Years 9 Months

Designation: VP-Operation

Reporting to: Managing Director

Job Responsibilities:

Quality functions:

1. Responsible for working with the Site Quality Head in implementing and continuously improving quality and regulatory policies and procedures for the manufacturing department.

2. Responsible for quality of products across the manufacturing process and ensuring zero critical defects.

3. Responsible for compliance to regulatory/cGMP/statutory/company policies in all areas of the Unit.

4. Responsible to monitor all operations of the Unit.

5. Responsible for active participation in the Product Quality Reviews (PQR), including but not limited to the recommending continuous product quality improvements.

6. Responsible for coordinating with all other departments for seamless manufacturing operation, implementation and compliance of cGMP and current regulatory requirements.

7. Responsible for ensuring that all the department staff are trained in accordance with their job function and associated Standard Operating Procedures (SOPs).

Production functions:

1. Responsible for planning and execution of production and packing tasks in a way that best optimizes the people and machine utilization.

2. Responsible for preparation of production plan and coordinating with cross functional department for precise execution of the production plans and better inventory control.

3. Responsible for periodical review and monitoring of the production plans to achieve the target within timeline.

4. Responsible to ensure high degree of discipline within the team.

5. Responsible for improving the productivity and product yield, while minimizing waste.

6. Responsible for continuously reviewing and updating the facility and equipment.

7. Responsible for maintaining facility and equipment in good operational condition.

8. Responsible for timely initiation and implementation of CAPA, deviation and change control within the manufacturing department.

9. Responsible for improving the product life cycle, efficient functioning of the department by effective men and machine utilization to reduce the production cost.

10. Responsible to participate in new product development and introduction.

11. Responsible for cleanliness and contamination control within the manufacturing process areas.

HR Functions:

1. Responsible for manpower planning ensuring optimum utilization of manpower.

2. Responsible for identifying and executing internal and external training needs in collaboration with Quality and HR departments.

Customer Relations:

1. Responsible for maintaining cordial relationship with all customers and getting proper support for effective Production Planning and delivery of manufactured goods.

2. Responsible to communicate the dispatch schedule to Customer.

Industrial Relations:

1. Responsible for maintaining a cordial relationship with all employees and to support individual departmental growth towards increasing production.

2. Responsible to ensure all rules and regulations of Archimedis are adhered to, and discipline is maintained.

3. Responsible for the enhancement of the capacity and capability of the unit.

4. Responsible to guide and support all the functional departments of the Unit.

Audit and complaints handling:

1. Responsible for acting as a Site representative while dealing with internal, external and other regulatory auditors.

2. Responsible to maintain the production area and other cross functional departments with high degree compliance to face any audit at any time.

3. Responsible to ensure audit readiness for the Unit according to regulatory/company requirements.

4. Responsible to initiate and implement the audit CAPAs.

5. Responsible to participate in market complaint investigation and implementation of corrective/preventive action to avoid reoccurrence of the same.

6. Responsible for continuous training for production employees to improve the system and to reduce the future audit observations.

Training:

1. Responsible to identify training need to production employees.

2. Responsible to conduct on the job training, technical training and other cGMP trainings.

Documentation:

Responsible to review:

1. All production equipments qualification documents

2. SOPs

3. Process Validation Master Plan

4. Process Validation Protocol and Report

5. Deviation

6. Change control

7. Batch documents

8. PQR

9. Market complaint and OOS investigation

Note: Any other activities shall be assigned by reporting authority.

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