Senior Data Review Specialist - Chemistry (Data Review)
- India
- Permanent
- Full-time
- Apply GMP/GLP principles consistently in all areas of responsibility.
- Review simple and complex routine and non-routine data across multiple areas according to departmental, corporate, and client SOPs.
- Evaluate laboratory documentation, analytical procedures, calculated results, and final reports for accuracy, clarity, and regulatory compliance.
- Communicate findings and recommendations clearly to laboratory personnel and internal clients.
- Perform complex calculations, integration reviews, and compound evaluations to ensure data is compliant and defensible.
- Serve as a technical advisor for analysts regarding QA/QC of data and support process improvement initiatives.
- Stay updated on professional trends and internal procedures, contributing to SOP development and training of new and existing team members.
- Master’s degree in a science-related field, with 7–10 years of experience in bio-pharmaceutical chemistry, drug product/substance testing, and data review responsibilities.
- Strong understanding of regulatory requirements and laboratory best practices.
- Experience with analytical techniques and data review, including pH measurement, XRD, KF, chromatography (HPLC/UPLC, GC, IC), and other relevant methods.
- Proficiency with laboratory software, such as Waters Empower, LIMS, and Electronic Notebooks.
- Excellent attention to detail, logical thinking, and strong analytical and mathematical skills.
- Effective written and verbal communication skills to interact with colleagues and clients.
- Ability to handle multiple tasks, prioritize work, and learn new procedures quickly.
- Demonstrated ability to coach and mentor peers.
- Competitive salary and potential for career growth.
- Flexible work environment with opportunities to collaborate with global teams.
- Professional development and training opportunities.
- Exposure to advanced analytical methods and cutting-edge laboratory technologies.
- Collaborative and scientifically rigorous work culture.
- Health and wellness benefits (as applicable per local policy).
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