Incorporated in 1993. Syngene is an internationally reputed custom research and manufacturing organization, which supports R&D programs from lead generation to clinical supplies. Our multi-disciplinary skills in integrated drug discovery and development include capabilities in medicinal chemistry, biology, in vivo pharmacology, toxicology, custom synthesis, process R&D, cGMP manufacturing, formulation and analytical development along with Clinical development services.
Job Title: Senior executive
- Working experience in Analytical method development, Excipient and device compatibility studies.
- Experience in Validation of analytical procedures, method transfers and stability studies for registration purpose by using HPLC, UPLC, GC with EMPOWER – 3, Auto titrator, Particle size analyzer, UV, FTIR, DSC and Polari meter.
- Preparation of method development, method validation protocols and reports as per the requirement.
- Abilities in Qualification, Calibration and troubleshooting of analytical instruments.
- To ensure that the instruments are 100% compliant for the intended purpose. Also, to see whether it is having 21 CFR part 11 compliance or not.
- Preparation of SOPs, IOPs and EOPs and provide training whenever required.
- Preparation of protocols and reports as per the regulatory & client requirements
- Working standard preparations and maintenance.
- Must have applicable knowledge in CGMP, ICH, USP and other regulatory requirements.