Senior Analyst

• Overall adherence to safe practices and procedures of oneself and the teams aligned
• Contributing to development of procedures, practices and systems that ensures safe operations and compliance to company’s integrity & quality standards
• Driving a corporate culture that promotes environment, health, and safety (EHS) mindset and operational discipline at the workplace at all times.
• Ensuring safety of self, teams and lab/plant by adhering to safety protocols and following environment, health, and safety (EHS) requirements at all times in the workplace.
• Ensure all assigned mandatory trainings related to data integrity, health, and safety measures are completed on time by all members of the team including self
• Compliance to Syngene’ s quality standards at all times
• Hold self and their teams accountable for the achievement of safety goals
• Govern and Review safety metrics from time to time
  

Core Purpose Of The Role

• Analysis of Raw Material/ In process samples/ cleaning samples/ Intermediate samples/Finished product/water sample/ Packaging materials/ Formulation finished products and management/traceability of Reserve samples and Visual inspection samples.
• Maintenance of sampling tools as per the standard operating procedure.
• Packing and Maintenance of reserve samples and visual inspection samples as applicable
• Carry out the analysis on the qualified techniques as per the approved specification/protocol/procedures and Interpret the data from analytical instruments and report the results and submit the completed documents for review promptly.
• Preparation of Certificate of analysis
• Recording of analytical observations/ findings, reporting of data and results in observation data sheets, forms, logbooks, LIMS and ELN application softwares.
• Reporting of any abnormal observation identified during analysis to reporting manager/Group leader/HOD immediately.
• Calibration of Instruments and perform HPLC lamp intensity test as per schedule, hot water flushing of HPLC and general preventive checks for laboratory instruments.
• Creation/ preparation of documents, master data/ static data creation in LIMS, ELN and LMS Softwares as applicable.
• Initiation of QMS elements and other documents in Trackwise and EDMS application softwares.
• Record updation for Outsourcing of sample testing based on requirement and updating respective Logbooks.
• Coordination with engineering & maintenance and external vendor for preventive maintenance and calibration activity.
• Initiation of Change control, CAPA, deviation, Laboratory Incident, OOS, OOT, Non-Conformity as applicable.
• Disposal of left-over Sample after review/approval of analytical report /Release.
• To indent the chemicals, glassware, document, instrument, and accessories required for performing analysis as per the plan.
• Archive and retrieve documents related to the section.
• Adherence to Good Laboratory Practice and Good documentation practices.
• Cleaning of workplace and following Good Laboratories Practices while working in QC Laboratory.
• Individuals working in the GMP environment are responsible for documenting/record the activities contemporaneously and accurately as per Good documentation practices.
• Handling of LMS, LIMS, ELN, TrackWise and EDMS Softwares for routine activities as applicable.
• Responsible for taking any other job allocated by Head QC / Group Leader /Section Head/ Section In-Charge.

• In addition, the responsibility of the standard management team as;
• Receipt, Inventory management, Qualification, Labeling, Dispensing of Analytical standards, removal and disposal of expiry standards and Storage of standards as per the appropriate storage condition used in Quality Control Laboratory.
• Review the status of Pharmacopoeial reference standards and their validity periodically.
• Preparation of Standard Qualification protocol, Report and COA as applicable.
  

• Excellence
• Integrity
• Professionalism
  

Skills And Capabilities