Officer Analytical Development Lab (ADL)

1. Routine calibration and / or verification of laboratory instruments and equipment.

2. Analysis of raw material, finished product, and stability samples of sterile ophthalmic and non-sterile dermatological products.

3. Chemicals, reagents, buffer solutions, mobile phases, and solution preparation as required for analysis.

4. Purified water analysis.

5. Handling and maintenance of laboratory consumables, glassware, chemicals, reference standards, working standards, chromatographic columns, etc.

6. Perform analytical method development & routine analysis on HPLC, GC, UV, FTIR, Density meter, Polarimeter, KF auto titrator, etc.

7. Perform Analytical Method Validation of Assay of Preservative, Antioxidant, and Related Substance by HPLC and Residual Solvent by GC.

8. Analytical Method : transfer of validated method to QC department of respective manufacturing location.

9. Documentation of analytical reports.

10. Preparation and / or review of documents such as analytical development approach paper, method development report, product specification and test procedures, method validation protocol and report, method transfer protocol and report, SOP, Formats, COA preparation, etc.

11. Coordination with service engineers for instrument and equipment maintenance and troubleshooting.

12. To be involved in the preparation and review of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents (wherever applicable) for the instruments and equipment that are to be installed in the ADL department.

13. Follow strict adherence to Good Documentation Practices and Good Laboratory Practices.

14. Support GDP, GLP, internal and external audits, and compliance-related activities within the department to be in line with QMS and USFDA requirements.

15. To attend the training organized by the internal department of the R&D Center or an external party.

16. To maintain sample Entry log.

17. Any other duties as per organizational requirements.

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Skills Required

Hplc, Uv, analytical method validation , Ftir, Qms, polarimeter , Gc