will be responsible for the development and validation of analytical methods, effective management of analytical projects, ensuring regulatory compliance, and supporting technical activities related to API and intermediate development.
Key Responsibilities:
Method Development & Validation
Develop and improve analytical methods (HPLC, GC, UV, IR, KF, etc.) for raw materials, intermediates, and APIs.
Conduct method validation studies covering accuracy, precision, specificity, sensitivity, linearity, and robustness.
Prepare method development protocols and validation reports with complete data analysis and interpretation.
Project Management
Work collaboratively to ensure project timelines are met.
Manage multiple analytical development projects by prioritizing tasks and allocating resources effectively.
Coordinate with Formulation, Process Development, QA, and Regulatory Affairs teams for smooth execution.
Regulatory Compliance
Ensure all developed and validated methods are compliant with applicable regulatory guidelines (ICH, FDA, etc.).
Stay updated with current regulatory expectations and industry best practices.
Review and prepare analytical documents in accordance with internal and external quality standards.
Technical Expertise
Perform statistical data analysis and interpret analytical results accurately.
Understand API manufacturing processes and potential challenges related to analytical method development.
Qualifications:
Education:
M.Sc. Chemistry / Organic, or related discipline
Experience:
2-4 years in ADL or Quality function within an API/pharma manufacturing setup.
Job Type: Full-time
Pay: ₹250,000.00 - ₹350,000.00 per year
Benefits:
Health insurance
Provident Fund
Application Question(s):
What is the Current CTC
What is the expected CTC (Is it negotiable )
Notice period
High Qualification
Reason for job changes
When will you be available for the face-to-face interview
Experience:
Five: 1 year (Required)
Work Location: In person
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