Senior Executive

Job Title Senior Executive Designation Analytical Analyst - ICP-MS ICP-OES Job Location Bangalore Department Analytical - Baxter Global Research Center BGRC About Syngene Incorporated in 1993 Syngene International Ltd is an innovation-focused global discovery development and manufacturing organization providing integrated scientific services to the pharmaceutical biotechnology nutrition animal health consumer goods and specialty chemical industries around the world Syngene s clientele includes world leaders such as Bristol-Myers Squibb Baxter Amgen GSK Merck KGaA and Herbalife Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems improve R D productivity speed up time to market and lower the cost of innovation Job Purpose To oversee method transfer validation activities related to elemental assay and trace analysis characterization of elemental impurities in trace and assay levels Key Responsibilities Planning of day to day activities and reviewing of documents To execute stability analysis validations and method transfers on Flame emission spectrometry FES Atomic Absorption Spectrophotometer AAS Inductively coupled plasma Optical Emission Spectroscopic ICP-OES and Inductively coupled plasma mass spectrometry ICP-MS techniques as on required within timeline Review of document generated on stability analysis validations method transfers and calibrations Execution of validation protocols and routine analysis Preparation of validation and stability protocols and reports Preparations of Standard Operating Procedures SOPs Emergency Operating Procedures EOPs and IOPs and provide training whenever required To prepare draft investigation report for the deviations Incidents Out of Control OOC and Out of Specification OOS To ensure the entire instrument for intended use meets the 21 CFR part 11 compliance To oversee the quality aspects of stability operations and ensure the compliance for stability testing and Laboratory information management system LIMS Attend training on environment health and safety EHS measures imparted company Follow environment health and safety EHS requirements at all times in the workplace ensuring individual and lab plant safety Educational Qualification M Pharm M Sc Technical functional Skills Should have hands on experience on ICP-MS ICP-OES AAS and FES and other wet analysis instrumentation Should be familiar with cGMP and ICH guidelines Good knowledge on US EU pharmacopoeias and its recent updates Should be through with stability operations Should have good hands on experience in execution of stability testing in line with ICH guidelines and strict adherence cGMP Exposure to USFDA audits thorough knowledge in maintaining the prerequisites in the implementation of 21 CFR Part 11 compliance will be treated as an added advantage Experience 3-5 years of relevant experience in Quality Control department Analytical Development Lab Behavioral Skills Good communication technical report writing skills and E- Mail etiquette Good team player Able to work follow instructions and perform the tasks under the supervision of the Team leader 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 disability