JOB DESCRIPTION
Designation: Research Associate (9-I) or Senior Research Associate (9-II)
Job Location: Bangalore
Department: BBRC PD ARD – GMP
Key Responsibilities:
- Testing of samples (drug substance and drug product for release testing and stability) using chromatographic, dissolution, and wet analytical techniques under a GMP environment following cGMP practices
- Analysis of API clinical campaign samples manufactured in Syngene pilot plant
- Qualification or requalification of API reference standards.
- Performing instrument calibration and qualification
- Performing method validation, and method transfers
- Troubleshooting HPLC, dissolution apparatus and other analytical instruments in the lab
- Deliver analytical results within the established windows and as per applicable guidelines
- Compliance & implementation of quality systems
- Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
- Electronic lab notebook documentation
- Miscellaneous lab responsibilities
Educational Qualifications: M.Sc. Chemistry for 9-I; M.Sc. Chemistry or M. Pharm for 9-II;
- The candidate should have a good educational and theoretical, analytical chemistry background
- Good knowledge of analytical techniques
- The candidate should understand instrument calibration, qualification, method validation, and analytical testing
- Good understanding of documentation as per GxP requirements (electronic notebook)
- The candidate should have good proficiency in MS office tools
- Experience in stability samples testing and good knowledge of ICH guidelines & cGMP regulatory requirements
- Must have worked in a cGMP-regulated environment, exposure to regulatory inspections like US FDA, MHRA, etc. is preferred.
Experience: 1-2 years with M.Sc. for 9-I ; 3-5 years with M.Sc. or 1-2 years with M. Pharm for 9-II
Behavioral Skills:
- Strong commitment toward work and a high level of dedication, enthusiasm, and motivation
- Good speaking-listening-writing skills, attention to detail, proactive self-starter
- Ability to work successfully in a dynamic environment
- Should be able to work in a team and flexible for working in shifts.
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