Hiring for Sr.Executive / Assistant Manager in CQA at Hetero Drugs

Hetero Drugs is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. Hetero’s business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Globally renowned, vertically integrated pharmaceutical player engaged in Research and Development (R&D), manufacturing, and marketing of high-quality chemical and biologic medicines across diverse therapeutic areas.

Post : Sr.Executive / Assistant Manager - CQA

Hiring for Sr.Executive / Assistant Manager - CQA for Formulations

Job Description
1. To ensure completion of Equipment / System qualification / Validation on time as per schedule.
2. Review of protocols and reports (IQ, OQ, PQ) for Equipment/Instrument/ Utilities/Trends of Purified water, Potable water and Environmental Monitoring.
3. To review User Requirement Specification and Design Qualification.
4. Monitoring and reviewing of qualification / validation activities.
5. Monitoring and reviewing of calibration and preventive maintenance activity / reports and schedules.
6. Physical round in service floor and mezzanine floors to ensure the compliance.
7. Preparation, review and up gradation of SOP’s and formats related to Qualification.
8. Review of changes and assessing the impact / risks for equipment’s, Utilities and facility installation / modification.
9. Evaluation of Incidents, Deviations and Change controls related to Qualification.
10. Compliance to GMP and Quality Policy.
11. Participation, Review and Execution of Computer system validations.
12. To participate in Self Inspection, Quality audits, Auditing of External agency and audit compliance.
13. Training to the personnel related to qualification activities.
14. Review of engineering drawings.