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Hetero
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Officer

Officer

Hetero

2 - 4 years

1 - 4 Lacs

Hyderabad Jadcherla

Posted:1 week ago| Platform:

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Skills Required

capa sap data validation quality control quality audit production ipqa bmr documentation gmp hplc change control oos qc process validation sop oot quality assurance qms manufacturing cleaning validation bpr review

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Responsible for preparation of Validation Master Plan, validation related SOPs and schedules.

2. Responsible for preparation of facility, equipment, area qualification protocols and reports.

3. Responsible for execution of facility, equipment and area qualification activities.

4. Responsible for operation and handling of Dataloggers, HVAC related equipments.

5. Responsible for compilation and review of validation raw data and test certificates.

6. Responsible for preparation of Installation qualification (IQ), Operational qualification (OQ) and Performance qualification (PQ), revalidation protocols and reports.

7. Responsible for execution of IQ, OQ, PQ, Revalidation of Equipments.

8. Responsible for In-process assurance of Engineering department activities like utilities monitoring, verification of log books, PMP records, review of Schedules and calibration records.

9. Responsible for co-ordination with user department and validation service providers for execution of qualification activities.

10. Responsible for handling of risk assessments, deviation, change control and incidents related to qualification/validation.

11. Responsible for preparation of Utilities Annual summary reports.

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