Syngene
Incorporated in 1993. Syngene is India’s largest contract research 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 Sr. Executive
Job Description:
- Daily laboratory monitoring, responsible to perform, record and review the daily/monthly Verification, calibration of Equipments and Instruments.
- Preparation of QMS documentation such as SOPs, IOPs, EOPs etc.
- Preparation of batch release documents like Specifications, TMRs with observation data sheet, verification protocols, Method transfer protocols etc.
- Responsible to perform the Method Transfer analysis and Verification activity with documentation for the samples of In-Process/Finished product.
- Responsible for the preparation of Stability study related documents like, Stability study Protocols, observation data sheet, analysis report, stability summary and trend sheets. Responsible for the execution of stability samples charging for stability study.
- Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples.
- Execution of In-process, finished product and stability sample analysis, documentation (Writing Observation data sheet, Updating of Stability summary sheet and Trend sheets) and recording of results in Technical information sheet and SAP.
- To ensure the review of Observation data sheet along with the analytical data for In-process, batch release and stability sample analysis.
- Responsible to Initiate and inform immediately to department HOD/designee, if there is any Laboratory
- Incidents, deviations, Change controls and out of specification results were observed.
- General lab support including housekeeping, equipment maintenance, inventory of supplies, etc.
- To prepare the complete list of materials (CLM) required for various project.
- To participating in cGMP/client audits and regulatory inspections as a technical liaison.
- Responsible to complete all planned Quality & Compliance training as and when required by the department/section or asked by the HOD/designee.
