Job in ADL Department at Windlas Biotech

Windlas Biotech (P) Ltd. a WHO GMP Certified pharmaceutical company. Manufacturer of pharmaceutical medicines like tablets & capsules. Liquid & Dry Syrups lor Domestic & ROW market since 2001, located in Dehradun, Uttarakhand. The vision of establishing an excellent manufacturing facility that caters primary to regulated markets.

Team Leader (Scientist) : ADL Department
Experience : 08 to 10 Yrs
Qualification : MSc. (Pharma Chemistry), Diploma (Pharmaceutical Management)
Salary Package : 06 Lac to 10 Lac
Job description:
1. Literature Search : To do literature search and compilation of products related matters and other relevant details which arc required during product development. To study various literature available regarding analysis, dissolution, analytical procedures, and characterization of new products. Must have experience for developing & working on Regulatory agency audit observations CAPA response independently.
2. Pre-formulation study: It contains innovator sample identification & characterization and recording the same in prescribed format. Development of comparative dissolution profde and dissolution media. Review of SOPs, BOM, BMR, BPR, Validation, Qualification and Quality or DI event documents.
3. Analytical Method development in line with ACTD/ICH guideline
4. To do method development of new products.
5. Transfer of methods for new products to QC through raw SIP.
6. BCS study & Dissolution development as per CTD
7. AMV/AMT with FD study. Review of all documents
8. Maintenance of lab equipment and instruments related to analytical development.
9. Documenting trial details of analysis in logbooks, maintaining the record product wise.
10. Assisting QC related w ork, troubleshooting in methods of QC as assigned from time to time
11. Any other Job responsibility assigned from management from time to time.

Analyst (Research Associate) Analysis & Documentation: - ADL Department.
Experience : 0-1 to 08 Yrs
Qualification : MSc. (Pharma Chemistry), Diploma (Pharmaceutical Management)
Salary Package : 04 Lac to 06 Lac
No. of Positions : - 02
Job description :
1. Pre-formulation study: It contains innovator sample identification & characterization and recording the same in prescribed format. Development of comparative dissolution profile and dissolution media.
2. Analytical Method development in line with ACTD/ICH guideline
3. To do method development of new products.
4. Transfer of methods for new products & preparation of its method transfer protocols Si reports to QC through raw STP.
5. BCS study Si report. Dissolution development & report as per CTD. Multimedia dissolution & report
6. AMV/AMT with FD study Si report preparation.
7. Maintenance of lab equipment and instruments related to analytical development.
8. Documenting trial details of analysis in logbooks, maintaining the record product wise.
9. Compilation of Multimedia dissolution with FI/F2.
10. Stability report compilation and review.
11. SOP, Specification & STP Preparation.