Galentic Pharma Senior Officer / Executive / Senior Executive (Analytical Development & Validation) job vacancy
Analytical Development And Research Associate
Job Title – Senior Officer / Executive / Senior Executive (Analytical Development & Validation)
Position open – 2
Experience – 3 to 9 years into Analytical Development & Validation (R&D)
Job responsibilities:
1. Analysis of raw material, finished product and stability samples of sterile ophthalmic and non-sterile dermatological products.
2. Analytical method development by using HPLC, GC, UV-Vis, FTIR, etc.
3. 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.
4. Analytical method development, method validation and review of data for IVRT.
5. Routine calibration and qualification of laboratory instruments and equipment.
6. Training coordinator for new joinee in Analytical Development team.
7. Technical evaluation of raw material including Drug Master File.
8. Review of development, validation data including both raw data as well as lab notebook.
9. Follow strict adherence to Good Documentation Practices and Good Laboratory Practices.
10. Method transfer for assigned projects and online monitoring of validation activity at GMP site.
11. Review Formulation Development documents including stability protocols, Drug-Excipient compatibility study protocols, QTPP and other as per project requirements.
12. Review documents and provide technical support to Rabale and Kandla QC team during method transfer and/or validation whenever applicable.
13. Perform installation and qualification procedure for instruments and equipment along with calibration of all instruments and equipment as required.
14. Co-ordination with service engineers for instrument and equipment calibration, maintenance and trouble shooting.
15. Support GDP, GLP, internal and external audit and compliance related activities within department to be in-line with QMS and USFDA requirement.
16. Prior exposure to audits like USFDA, EU, TGA preferred.
18. Effective planning, quality execution and organization of work is a must.
19. Any other duties as per organizational requirements.
Candidate should have experience into Topical semi-solids formulations
Job Location – Andheri East, Mumbai R&D center
Interested candidates apply at [email protected]
