Scientific Document Reviewer
2 months ago
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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