Syngene
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.
Our highly experienced scientific and project management teams ensure:
- Timely execution of projects
- Cost effectiveness and quality of the projects
- Confidentiality and protection of intellectual property
Job Title:Â Â Â Lead – Development QA Formulations
Job Description:
- Responsible for Quality assurance activities of Formulation and analytical development in Syngene.
- Review of technology transfer documents
- Approval of Analytical development specifications, test methods and method development reports
- Review of Process development summary reports, stability reports and QbD documents
- Issuance, review and control of laboratory notebooks and equipment usage logs.
- Assessment of change controls, deviations and incidents for development activities
- Review of process risk assessment and MFRs
- Review of audit trails in analytical instruments
- Effective Communication with clients on QA activities for a project
