Scientific Document Reviewer

2 months ago


Bengaluru, Karnataka, India Syngene Full time

Job Title: Document Reviewer

About the Role:

The Document Reviewer will be responsible for reviewing technical documentation and records in a report format. This includes providing assistance in the preparation of SOPs and executing review documents in accordance with planned timelines.

Key Responsibilities:

  • Review technical documentation and record review in a report format.
  • Provide assistance/participate for the preparation of SOPs.
  • Execution of review documents in accordance with planned timelines.
  • Technical data reviews for studies utilizing analytical skills, technical knowledge, and 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.
  • 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 by the company.

Requirements:

  • Master's degree in Biological Sciences (Preferably Biochemistry background) or a related field.
  • 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.
  • 6-9 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:

Syngene is an equal opportunity employer and provides reasonable accommodations for qualified individuals with disabilities.



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