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Associate Scientist - Document Reviewer

6.00 to 8.00 Years   Hyderabad, Kolkata, Pune, Mumbai City   01 Jun, 2022
Sygene
Job LocationHyderabad, Kolkata, Pune, Mumbai City
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaGeneral / Other Software
EmploymentTypeFull-time

Job Description

    Designation: Associate ScientistJob Location: BangaloreDepartment: Immunogenicity Research LabAbout SyngeneSyngene International Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated research, development and manufacturing services company serving the global pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical sectors. Syngene s 4500+ scientists offer both skills and the capacity to deliver great science, robust data management and IP security and quality manufacturing, at speed, to improve time-to-market and lower the cost of innovation. With a combination of dedicated research facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, as well as 1.9 Mn sq ft of specialist discovery, development and manufacturing facilities, Syngene works with biotech companies pursuing leading edge science as well as multinationals including GSK and Merck KGaA.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:6 - 8 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 :
document reviewanalytical skillshplcdocumentationvalidation

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