Biological Sciences Document Reviewer at Syngene – Apply Now!

Biological Sciences Document Reviewer at Syngene – Apply Now!

Title: Document Reviewer

Date: 29 Oct 2024

Job Location: Bangalore

Pay Grade: 8-I

Year of Experience: 6 – 9 Years

JOB DESCRIPTION

Designation: Associate 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 worldwide. Syngene’s clientele includes global leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA, and Herbalife. Its innovative culture is driven by the passion of its 4,240-strong team of scientists who collaborate with clients globally to solve scientific problems, improve R&D productivity, accelerate 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 in the preparation of SOPs, etc.
• Execute review documents according to planned timelines
• Conduct technical data reviews for studies, utilizing analytical skills, technical knowledge, and excellent regulatory guideline requirements
• Focus attention on detail review and identify critical observations
• Conduct routine reviews of laboratory logbooks, equipment calibration, and validation status, etc.
• Handle multiple studies’ data reviews 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 EHS measures provided by the company

Educational Qualification:

• Master’s degree in Biological Sciences (Preferably Biochemistry background) or a related field

Technical/Functional Skills:

• Proficiency in MS Office applications
• Experience in handling and participating in audits is preferable
• Knowledge and experience with regulatory requirements (e.g., OECD, GXP, 21 CFR Part 11, EMA, FDA guidelines)

Experience:

• 6-9 years of total experience in document review

Behavioral Skills:

• Ability to work independently
• Excellent communication skills, both written and oral, in English
• Strong interpersonal skills
• High flexibility and capacity to work under time pressure

APPLY ONLINE HERE

Keywords: Document Reviewer Job, Bangalore, Syngene, Biological Sciences, Document Review, Regulatory Affairs, Clinical Development. Biological Sciences Document Reviewer at Syngene – Apply Now! Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.