Pharma & Pharmaceutical Sciences Jobs Syngene
Syngene International Ltd., a global leader in integrated research and development, is hiring a Document Reviewer (Executive – QC, Small Molecule Bioanalytical Laboratory) in Bangalore, India. This role provides pharmacy professionals with the opportunity to contribute to high-impact bioanalytical research, ensuring data accuracy, compliance, and excellence in regulated environments.
- Role: Executive – QC, Document Reviewer, Small Molecule Bioanalytical Research Laboratory
- Job Grade: Level 9-I
- Location: Bangalore, Karnataka, India (560100)
- Reporting To: Head / Group Leader – Small Molecule Bioanalytical Laboratory
About the Company
Syngene International Ltd. is a leading integrated research, development, and manufacturing solutions company serving global pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and specialty chemical industries. With over 4,500 scientists and 1.9 million square feet of world-class facilities, Syngene partners with top global organizations, including Amgen, Baxter, Bristol-Myers Squibb, Herbalife, GSK, and Merck KGaA, to accelerate innovation, improve time-to-market, and reduce the costs of drug discovery and development.
Education:
M. Pharm / B. Pharm / M.Sc. in Pharmaceutical Sciences
Industry Experience:
- Minimum of 3 years of experience in regulated small molecule bioanalysis.
- Experience working in a Bioanalytical CRO lab is advantageous.
Job Description
The Document Reviewer (Executive – QC) will play a crucial role in ensuring the quality and compliance of data generated in the Small Molecule Bioanalytical Laboratory. This includes reviewing data for method development, validation, and sample analysis for BA/BE studies. The role demands strong scientific knowledge, attention to detail, and commitment to regulatory compliance.
Document Reviewer (Executive – QC) Key Responsibilities:
- Perform data check (QC) for method development, validation, and study sample analysis.
- Review STPs, Protocols, validation, and bioanalytical reports.
- Ensure studies adhere to regulatory guidelines and expectations set by GCP/GLP.
- Discuss QC observations with the Project Leader/Group Leader/Head, BRL for corrective actions.
- Prepare QC observation trend analysis and discuss with management regularly.
Core Competencies
- Strong scientific curiosity, innovation, and problem-solving skills.
- Technical expertise in ICH, FDA, EMA, and ANVISA method validation guidelines.
- Excellent organizational and project management skills.
- High standards in documentation, adhering to ALCOA++ policy.
- Strong English communication (written and verbal).
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