Salary300,000 - 660,000 INR (PA)
Job TypeFull Time
Job Location Gurgaon,Haryana,India


Chemical Engineering API sterile API sterile bulk drugs sterile active pharmaceutical ingredient parenteral api sterile active pharma injectables api sterile bulk sterile active pharmaceuticals
0 to 8 Years
Pharma / Biotech / Life Science
Functional Area
Production / Service Engineering / Manufacturing / Maintenance

Job Responsibilities
1. Adhere to the safety norms, company policies and procedures.
2. To ensure the availability of man, machine and material to achieve the production plan in the area of working.
3. Maintaining cGMP practices in production area and obtaining line clearance from QA to start the activity.
4. Responsible for activities like unit preparation, filter integrity testing, operation of steam sterilizer(Autoclave) and related online documentation in BMR, log-books, PAS|X and SAP as per Good Documentation Practice.
5. Responsible for adhering to the requirements of new product in the production area.
6. Coordination with IPDO team for new process/technology transfer at plant
7. Responsible for overlooking the activities of the Compounding Facility like Equipment Installation, Commissioning and Qualification.
8. Handling of Solvent like Heptane, ethanol & Methanol and solvent Usage in the Compounding Block, Readiness of the area for execution.
9. Responsible for Process utility operation like hot oil & cold oil circuit.
10. Responsible for Sterile API manufacturing process in compounding block
11. To Receive the log-books, BPR and other GMP records from QA/IPDO. Review and submission of the same to QA/IPDO.
12. Dispensing/receipt of materials as required from warehouse/engineering stores etc.
13. To ensure and maintain the stock requirements for the Compounding Block.
14. Responsible for overlooking the Compounding Block while in project stage and executing the batches with the IPDO Team.
15. To ensure the qualification time-lines of the equipment are in line with the man power and logistic availability in the plant.
16. To coordinate for timely completion of calibration, preventive maintenance, Qualification /validation of equipment as per schedule.
17. Co-ordination with other related departments i.e. Ware house, Engineering, QA, QC, SHE, administration, F&D, TTG etc. for day to day activities.
18. To coordinate for the quality notification i.e. CRN, incident, CAPA as per requirement.
19. To prepare SOP, BMR,URS, Investigation reports, risk assessment reports and other GMP documents as required.
20.  Participation in media fill as per the schedule.
21.  Responsible for the qualification activities in the Compounding Block.
22. Responsible for GMP audits in the facility.
23. On time completion of training as per the matrix.
24. Training the shop floor team for solvent handing & Sterile API process.
25.  Responsible for transfer of equipment as per the product requirements.
26. To perform any other task/project assigned by Production head.

Disha Career Services
Disha Career Services
Sector-63, Noida
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