As one of the world’s leading pharmaceutical companies, Intas is committed to fulfilling the unmet global medical needs through comprehensive progressive and affordable medical products.To fuel its ever-expanding vision, Intas Pharmaceuticals is looking for elite professionals aiming to take their careers to the next level through the following positions.
- Role: Officer / Sr. Officer / Research Associate
- Department: QUALITY CONTROL (API) & REGULATORY AFFAIRS (API)
- Experience: 01 to 06 yrs
- Job Location: Ahmedabad
REGULATORY AFFAIRS (API)
- DMF Preparation, review and submission according to latest requirements.
- Preparation and review of query responses.
- Filing of amendments & Lifecycle management as per requirement.
- Co-ordination with cross functional departments for documents (Evaluation of route of synthesis, impurity profiling, Process validation, analytical method validation as well other development data) required for regulatory submission.
- Post approval changes and its filing & deficiency responses to various health authorities.
- Finalization of key starting material and designing various specifications to cater the requirement of filing to regulatory authorities.
QUALITY CONTROL (API)
- Experience in API plant
- To performed instrument qualification activity, instrument calibration & maintenance activity, all GLP activity.
- Preparation of SOPs
- Experience on instrument like HPLC, GC, FTIR & UV.
- Experience of analysis of RM, inprocess & FP of API plant.
- Able to perform analysis independently
Date of Interview: 25th December, 2021
Time: 9.30 AM – 1.30 PM
Venue: Intas Pharmaceuticals Ltd.,Matoda 457/458, Sarkhej – Bavla highway, Matoda, Taluka: Sanand,Ahmedabad- 382210