Title: Document Reviewer
JOB DESCRIPTION
Designation: Senior Research Associate – 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:
• 3-6 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.