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Senior Executive

Senior Executive

Hetero

4 - 7 years

2 - 6 Lacs

Hyderabad Jadcherla

Posted:1 week ago| Platform:

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Skills Required

pharmaceutical usfda quality control data validation iso production bmr ipqa documentation logistics gmp research hplc change control operations sop compliance quality assurance qms manufacturing solid orals formulation development inspection

Work Mode

Work from Office

Job Type

Full Time

Job Description

1.Responsible for giving line clearance between startup of various finished product formulation and filling operations.

2.Responsible for performing in process checks during finished product operations as per respective established procedures.

3.Responsible for Monitoring and Coordination of process validation, Hold time studies, media fill and cleaning validation activities.

4. Responsible for preparation of IPQA SOPs and review of finished product SOPs.

5. Responsible for preparation of Annual Product Review Reports.

6. Responsible for continued process verification reports.

7.Responsible for compliance to GMP in finished product area.

8.Responsible for review of all finished product log books.

9.Responsible for review of master MFR and executed BFRs.

10.Responsible to attend training programs and SOP trainings.

11.Responsible for preparation of media fill BFR, protocol and report.

12.Responsible for monitoring of stability samples.

13.Responsible for preparation and review of visual inspection qualification protocol and report.

14.Day to Day Manufacturing observations Report to Manager QA.

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Hetero

Pharmaceuticals

Hyderabad

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Senior Executive