Detailed / Profile:

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 solution, Mobile phase, solutions preparation required for analysis.

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

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

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

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

8. Support installation and qualification procedure for instruments and equipment along with calibration of all instruments and equipment as required.

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.



Co-ordination with service engineers for instrument and equipment maintenance and trouble shooting.

12. Co-ordinate with supporting departments at H.O., R&D;, Rabale Plant, Kandla Plant and vendor customer, external lab, consultant etc. as and when required.

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

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

15. Any other duties as per organizational requirements.

Candidate profile

1. Preferred candidates from semi - solid dosage form and have a relevant experience
2. The ideal candidate should have a B. Pharm/M.Pharm or M.Sc. in Chemistry/Pharmaceutical Analysis with relevant experience in Analytical R&D; or QC within the pharmaceutical industry.

3. The candidate should possess hands-on expertise in HPLC, GC, UV, FTIR, method development, validation, method transfer, and routine analysis of pharmaceutical products. A strong understanding of GLP, GDP, ICH guidelines, and regulatory requirements (USFDA/regulated markets), along with excellent documentation, troubleshooting, and cross-functional coordination skills, is essential.

4. Experience with sterile ophthalmic or dermatological formulations will be an added advantage.

📌 Documentation Professional (Gandhidham)
🏢 Galentic Pharma
📍 Gandhidham