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Hetero
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Senior Executive

Senior Executive

Hetero

6 - 9 years

2 - 6 Lacs

Hyderabad Jadcherla

Posted:1 week ago| Platform:

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Skills Required

pharmaceutical data validation gmp change management hplc change control lims oos qc operations oot sop qms reservation solid orals uv capa sap ointment liquid orals documentation analytical method validation liquid compliance quality assurance

Work Mode

Work from Office

Job Type

Full Time

Job Description

1. Preparation and Maintenance of SOPs, STPs, Specifications, GTPs and Worksheets related to Product testing.

2. Preparation, revision, review and execution of Analytical method Validation protocols and reports related to product testing.

3. Responsibilities for preparation of masters (Product, Specifications, Tests, worksheets, Test plans and TTD etc.) in LIMS.

4. Responsibilities for effective documents (STPs, Specifications and GTPs etc.) uploaded in LDMS.

5. Responsible for material management like weekly, monthly indent Ensure monthly indents are placed and materials received in timely manner, reservation placed through SAP. Ensure compliance `w.r.t expiry, usage and discard of materials.

6. Operation and calibration of QC Instruments related to product testing.

7. Testing and release of product samples by techniques such as:

General tests (Physical appearance, pH, Color, Extractable volume, Osmolality, Conductivity, etc.)

Gel Electrophoresis (IEF, SDS-PAGE, etc.)

Colorimetric assays (Sialic acid, Quantification of Polysorbate 80 and Polysorbate-20, etc.)

Quantification assays (Protein concentration by absorbance (Spectral scan)/Protein content by UV (OD @ 280 nm, Trehalose dihydrate, Mannitol, Sucrose, etc.)

ELISAs (Host Cell derived Proteins, Protein A Leachate, etc.)

Q-PCR (Host Cell DNA, Mycoplasma testing etc.)

HPLC techniques (Product concentration by RP-HPLC, Size Exclusion chromatography, Peptide mapping, etc.)

UPLC techniques (Cation exchange chromatography, Protein A Chromatography, N-Linked Glycans by hydrophilic liquid interaction chromatography, etc.)

8. Preparation of reagent solutions, buffers and maintenance of the records.

9. Temperature and humidity monitoring of labs and instruments.

10. Sample receiving, A.R. No allotment, Testing, Documentation and reporting of analytical results in LIMS for In process, batch release, stability and Miscellaneous samples related to product testing.

11. Withdrawal and aliquoting of batch release and stability samples for analysis.

12. Responsible for preparation of shift schedules and test planning activities.

13. Responsible for cGLP compliance.

14. Responsible for handling of OOT (Out Of Trend), OOS (Out Of Specification), Incidents, LIRs and Change controls related to product testing.

15. Responsible for change management: Ensure CRNs initiation and closure within target date.

16. Preparation, revision and review of miscellaneous protocols and reports related to product testing.

17. Review of analytical data and work sheets related to product testing.

18. Maintenance of stability samples and reserve samples related to product testing.

19. Responsible to execute the assigned activities in LIMS, TRIMS, DMS or any other software applications.

20. Responsible for usage, monitoring and verification of all kind of laboratory books.

21. Preparation, execution and review of reference standard qualification.

22. Maintenance of all QC documents related to product testing.

23. Assist in execution of Analytical method validations.

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Hetero

Pharmaceuticals

Hyderabad

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Senior Executive