Production - officer / Executive

Roles and Responsibilities:

Experience required 2-5 years

1. Responsible for planning & controlling production activities.
2. To resolve /escalate concerns (OOS, OOT, RM issues) in discussion with respective/concerned departments.
3. To review and approve batch manufacturing and packing record, SOPs, change control, deviation, qualification and related all documents.
4. To participate in audit processes with plant production and cross functional teams for relevant audits.
5. To monitor and review timely execution of pre-validation and validation batches: to share inputs with plant head for commercialization of product developed based on validation/exhibits batches.
6. Co-ordination with engineering/ external agencies for maintenance/ machine breakdown/ modification/ calibration.
7. To take CAPA/Change control/Deviation about market complaints.
8. To identify priorities and deploy action items for competency developments in the team.
9. Proper Segregation of material, labelling and identification, area cleaning and disinfection.
10. Preventive maintenance and calibration according to schedule.
11. Check on production yields and reconciliation at various stages of manufacturing.
12. Maintaining equipment’s and area cleanliness.
13. To assure batch uniformity and integrity of drug products through written procedures followed by in process controls and tests of each batch.
14. To monitor outputs and validate the performance of manufacturing process compliances with cGMP norms.
15. Perform inter-different training and schedule training.
16. To check the quality system in the production department.
17. Preparation of BMR’s, SOP’s and formats.
18. To comply with the requirements of technical Audits.

Daily records, Batch Manufacturing Record, Equipment Cleaning Record and related all logbooks updation.