Dey. General Manager

2 days ago


INDIA AHMEDABAD GUJARAT VIROCHAN NAGAR STAFF WEST Troikaa Group Full time ₹ 12,00,000 - ₹ 36,00,000 per year

1) Sound theoretical & practical knowledge of analytical method development, analytical method validation and analytical method transfer.

2) Good knowledge and practical hands on experience of reverse engineering for identification and quantification of chemical composition of innovator samples (Q1, Q2 & Q3).

3) Performs Quality Risk Assessments and generates technical documentation including analytical development reports, transfer protocols, validation protocols, validation reports etc.

4) Mentors and may lead team members on day to day activities and new projects.

5) Sound Knowledge of HPLC method development and method validation for Assay, Related substance, IVRT and IVPT of Semi-Solid/Topical Dosage Forms (Ointment, Creams, gels etc.).

6) Sound knowledge of analytical instruments HPLC, UPLC, GC, Dissolution Apparatus, Franz-Diffusion cell, Infrared spectrophotometer, UV spectrophotometer, Auto titrator, Karl Fisher, Viscometer, Rheometer with analytical data interpretation for characterization of physical properties.

7) Knowledge of UPLC method development, conversion of analytical method from HPLC to UPLC, multimedia dissolution study etc.

8) Sound knowledge of characterization of reference products for selection of right packaging material, API particle size using sophisticated instruments and techniques.

9) Ensures adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection regulations.

10) Assists QC and Quality Assurance in investigations of different issues and recommends solutions.

11) Provides timely response to requests for support of manufacturing deviations, investigations and change requests.

12) Ensures that all executed and documented activities are aligned as per company policies and objectives.

13) Good hand of experience of to perform the drug excipient compatibility study and evaluation of analytical data to give the conclusive information to Formulation and developments team.


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