Method Validation Expert

Designation Method validation expertJob Location BangaloreDepartment Analytical DevelopmentAbout SyngeneSyngene 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 spiritMandatory 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 Performing analytical method validations and related documentations Performing analysis RM PM Intermediates API and Finished products Key Responsibilities Following Good Laboratory Practices while working in QC Laboratory To maintain and clean responsibility allotted for individual instrument Use of required safety apparels while sampling analysis and working in the laboratory Carryout the analysis of validation samples as per the protocol Initiation of laboratory incident and deviation Preparation of calculation sheets and making draft reports Disposal of sample for analysis after use Taking any other job allocated by HOD or Section Head Analysis of Intermediate finished product and Working standard qualification as per the specification Ensuring verifying and reviewing the instrument usage log periodically and accordingly checking the labels as per SOP Preparation of protocols and Observation data sheets Should be well versed with latest analytical technique like HPLC GC KF KFC IR UV LC-MS GC-MS IC and ICP-OES ICP-MS etc Well-versed with Chromeleon data management application and LIMS will be an added advantage Educational Qualification M Sc M Pharma Analytical General chemistry Technical functional Skills Should be well versed with latest analytical technique like HPLC GC KF KFC IR UV LC-MS GC-MS IC and ICP-OES ICP-MS etc Well-versed with Chromeleon data management application and LIMS will be an added advantage Experience 6 - 9 yearsBehavioral Skills Should be an adaptive learner Should demonstrate effective Communication skills Organization and able to balance work and Life Should possess good Time Management abilities LIMS ELN Trackwise Chromeleon will be an added advantage 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