Senior Analyst

JOB DESCRIPTION Job Title Senior Analyst Job Location Syngene International Limited Bengaluru About Syngene Syngene is an innovation-led contract research development and manufacturing organization offering integrated scientific services from early discovery to commercial supply At Syngene safety is at the heart of everything we do personally and professionally Syngene has placed safety at par with business performance with shared responsibility and accountability including following safety guidelines procedures and SOPs in letter and spirit Mandatory expectation for all roles as per Syngene safety guidelines 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 This is an exciting opportunity to play a role in the Quality control department of Syngene The role will provide several responsibilities of Analysis documentation Lab safety requirements Compliance as per Syngene policy and EHSS requirement It provides an opportunity to handle overall analysis of QC and Stability samples Role Accountabilities 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 Syngene Values All employees will consistently demonstrate alignment with our core values Excellence Integrity Professionalism Specific requirements for this role Experience 3-6 years Skills and Capabilities Expertise in handling multiple Instruments equipment like HPLC Dissolution tester KF and GC Capable of thinking scientifically to address complex problems and develop solutions Work as a team and have a collaborative mindset Good communication skills Education MSC B Pharma Equal Opportunity Employer It is the policy of Syngene to provide equal employment opportunity EEO to all persons regardless of age color national origin citizenship status physical or mental disability race religion creed gender sex sexual orientation gender identity and or expression genetic information marital status status with regard to public assistance veteran status or any other characteristic protected by applicable legislation or local law In addition Syngene will provide reasonable accommodations for qualified individuals with disabilities