Block Head - API Production

Recruiter

Mohaneswara Reddy

https://www.linkedin.com/in/mohaneswarareddy

Role & responsibilities

The responsibilities are

Operations, Control and Monitoring

1. Improving, continuous reviewing and up gradation of existing production SOPs and work systems to ensure their strict implementation in respective block.

2. Resolution and identification of maintenance related activities of equipment and facility and making sure those are closed appropriately

3. Executing proposed changes in product, process or equipment and facility.

4. Preparing production plan and supervising the API and Intermediate batches as per production plan.

5. Ensure facility upkeep is maintained all the time.

6. Any other assignment given by management.

7. Communicating concerns with cross functional and service departments.

8. Control and monitor departmental opex budget.

9. Monitoring and controlling of effluent generation from manufacturing block.

10. Periodic review and monitoring of inventory in coordination with unit stores and supply chain.

11. Executing and monitoring of validation of new product, CIP, AVD with the help of cross functional team.

12. Implementation of new technology w.r.t. process equipments or facility.

13. Supporting quality assurance team for DMF submission.

14. Executing and supervising training, validation, qualification and calibrations protocols.

15. To perform visual inspection and certification of cleaned equipment after product change over cleaning as per standard operating procedure.

cGMP:

1. Following departmental standard operating procedures (SOP) and providing suggestions for SOP simplification and any other improvements.

2. Making sure all the documents and checklist are verified before and after manufacturing.

3. Ensuring retention and destruction of records are maintained in a department.

4. Verifying status labelling of accessories, in-process instruments, containers, area & equipment

5. Performing contemporaneous (on time) document entries.

QMS / OTHER SOFTWARE SYSTEMS:

1. Operating software systems like SAP, Quality Management System, Track wise system, Cipdox software, PR approval, LMS, Ariba, PPDS and E-Track system etc. based on roles and rights provided in the applications.

2. Compiling Annual product quality review along with quality assurance department and other CFT.

3. Participating and contributing to investigation for any non-conformance along with CFT.

EHS:

1. Following Environment, Health and Safety policies and practices.

2. Making sure personnel health, hygiene and organisation practices are followed.

3. To conduct risk analysis of product, system, equipment, process as per standard procedure.

Training

1. Attaining training as per training need and providing training to sub-ordinates through available software of Learning Management System (LMS).

Energy Management system (EnMS)

1. Participating in EnMS audits & Leadership rounds.

Preferred candidate profile

B.Tech Chemical with minimum 10 years of API production experience including experience to handle a block/section in a API plant.