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24/02 Sanketa Pednekar
HR at Ajanta Pharma

Views:2226 Applications:116 Rec. Actions:Recruiter Actions:0

Ajanta Pharma - Sr. Officer/Asst. Executive - DRA ANDA - Quality Control (2-7 yrs)

Mumbai Job Code: 2620

Department : Quality Control

Desired Position : Officer / Executive (LIMS, HPLC, GC, Micro, RM,PM,FP, GLP, Documentation)

No. of Positions : 40

Exp. Req. : 2 to 7 years

Qualification Req. : B.Sc / M.Sc

Salary Budget : 3 to 6 Lacs

Note : (Candidate shall be from Pharma Formulation tablet/capsule manufacturing plant background and having experience of WHO, USFDA, MHRA, Regulatory affairs)

Designation : Sr. Officer/Asst. Executive- DRA ANDA

CTC : Rs.6.50Lacs.

Job description :

1. Review of master Formula record, Batch manufacturing Record, Batch Packaging Record.

2. Review of Process Validation protocol & Report.

3. Preparation of Write - Ups for manufacturing section, compilation of documents for ANDA submission.

4. Co-ordination with manufacturing location to procure corrected documents.

5. Review of Pharmaceuticals Development Report.

6. Review of Master Formula Record, Batch Manufacturing Record, Batch Packaging Record.

7. Review of Process Validation Protocol & Report

8. Preparation of Write-ups for Manufacturing section, Compilation of Documents for ANDA submission in eCTD format.

9. Co-ordination with manufacturing location to procure corrected documents.

10. Review of Pharmaceutical Development Report.

11. Handling preparation of labels and pack inserts.

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