Document Reviewer

2 weeks ago


Bengaluru, Karnataka, India Syngene International Full time

Designation Research Scientist - Document Reviewer Job Location Bangalore Department Clinical Development 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 productivity speed up time to market and lower the cost of innovation Job Purpose The position holder is responsible for document review related to Bioanalysis including Pharmacokinetics and Immunogenicity Key Responsibilities Review technical documentation and record review in a report Provide assistance participate for the preparation of SOPs etc Execution of review documents in accordance with planned timelines Technical data reviews for studies utilizing analytical skills technical knowledge and utilizing excellent regulatory guidelines requirements Capable to focus attention to detail review and identify critical observations Routine review of laboratory log books equipment calibration and validation status etc Handle multiple studies data review simultaneously in an efficient and effective manner Follow environment health and safety EHS requirements at all times in the workplace ensuring individual and lab plant safety Attend training on environment health and safety EHS measures imparted company Educational Qualification Master s degree in Biological Sciences Preferably Biochemistry background or a related field Technical functional Skills Good knowledge of MS Office applications is necessary Handling audits and participation in audits is preferable Knowledge and experience with regulatory requirements e g Organization for Economic Co-operation and Development OECD GXP 21 CFR Part 11 European Medicines Agency EMA and Food and Drug Administration FDA guidelines Experience 12-15 years of total experience in Document review Behavioral Skills Should be independent Excellent communication skills - written and oral in English Should have good interpersonal skills Large degree of flexibility and ability to work under strong time pressure 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



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