Senior Research Associate - Document Reviewer

2.00 to 7.00 Years Bangalore, Chennai, Hyderabad, Delhi 17 Dec, 2021

Job Location	Bangalore, Chennai, Hyderabad, Delhi
Education	Not Mentioned
Salary	Not Disclosed
Industry	Education / Training
Functional Area	General / Other Software
EmploymentType	Full-time

Job Description

Designation: Senior Research Associate Document ReviewerJob Location: BangaloreDepartment: Clinical DevelopmentAbout SyngeneIncorporated 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 reportProvide assistance/participate for the preparation of SOPs etc.Execution of review documents in accordance with planned timelinesTechnical data reviews for studies utilizing analytical skills, technical knowledge and utilizing excellent regulatory guidelines requirementsCapable to focus attention to detail review and identify critical observationsRoutine 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 companyEducational Qualification: Master s degree in Biological Sciences (Preferably Biochemistry background) or a related field.Technical/functional Skills: Good knowledge of MS Office applications is necessaryHandling audits and participation in audits is preferableKnowledge 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: 2-5 years of total experience in Document review.Behavioral Skills: Should be independent.Excellent communication skills - written and oral in EnglishShould have good interpersonal skillsLarge degree of flexibility and ability to work under strong time pressureEqual 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.,

Keyskills :
continuous improvement facilitationlegislative relationsequipment calibrationhplcanimal healthresearchliteraturenmrvalidationcommunication skillsregulatory guidelinesdocument reviewequal employment opportunityanalytical skills21 cfrtechn

APPLY NOW