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QA QUALIFICATION ASSISTANT MANAGER Full-time Job

5 days ago Pharma Hyderabad   6 views
Job Details

Hello,

Greetings from Hetero Labs

We have a requirement for Assistant Manager position in QA Qualification section.Below mentioned are required for the position.

Job Description:

1. Responsible for preparation and review of Quality Assurance SOPs.
2. Responsible for review of cross functional department SOPs.
3. Responsible for preparation, review and updating of master documents like SMF & VMP.
4. Responsible for review of area, equipment / instrument and facility qualification protocols and reports.
5. Responsible for preparation and execution of area, equipment / instrument and facility HVAC, Purified Water qualification protocols.
6. Responsible for review of Qualification / Validation data and preparation of reports.
7. Responsible for verification of vendor documents with respect to Equipments / instruments, Utility, HVAC area, Purified Water System.
8. Responsible for review of change request notes, deviations, incidents etc.
9. Responsible for review of Quality Records of other departments.
10. Responsible for ensuring engineering assurance (Review of log books, calibration schedule execution and PMP schedule execution).
11. Responsible for compliance of cGMP.
12. Responsible for maintenance of Quality Policy.
13. Responsible for conducting internal audit routine GMP inspection in the plant & Vendor Audits
14. Responsible to attend the training programs & conducting SOP and GMP trainings.
15. Responsible for coordination with PD, WH, EN & QC department regarding validation activities.
16. Responsible for preparation & review of risk assessment, PMP Schedules, PMP check list, calibration schedules, calibration certificates, water trend & environment trends.
17. Responsible for verification of external certificates.
18. Responsible to attend the training programmes.
19. Responsible for submission of analysis samples to QC Laboratory.
20. Responsible for Review, Updation and Implementation of Current Regulatory Requirements.

Job Location : Jadcherla

Regards,

Team HR

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Company Description
Hetero is an Indian pharmaceutical company and the world’s largest producer of anti-retroviral drugs. It is also among the world’s leading producers of key Active Pharmaceutical Ingredients with presence in 145+ countries and backed by 30 years of experience in the pharma sector.