RESEARCH ASSOCIATE – II
Location: Dholka, India
Company: Cadila Pharmaceuticals Ltd
Department: Research & Development – Analytical Development
Domain: Analytical Method Development & Validation
JOB OVERVIEW
The Research Associate-II is responsible for supporting and reviewing analytical method development, method validation, and method transfer activities in accordance with current regulatory requirements. The role involves data review, troubleshooting analytical issues, regulatory query support, documentation management, and ensuring compliance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP).
KEY RESPONSIBILITIES
• Analytical Method Development & Validation
Monitor analytical method development activities.
Review analytical method development data.
Review analytical method validation protocols and reports.
Ensure validation activities comply with current regulatory requirements.
• Method Transfer Activities
Review method transfer protocols and reports.
Coordinate with manufacturing and plant sites during method transfer activities.
Support successful transfer of analytical methods between laboratories and production sites.
• Regulatory Support
Review and respond to regulatory queries received from various health authorities.
Prepare scientific justifications and technical responses.
Support regulatory submissions and documentation.
• Documentation & Compliance
Prepare and review Standard Operating Procedures (SOPs).
Maintain compliance with GLP and GDP requirements.
Ensure proper documentation and record maintenance.
Maintain analytical reports and release them to concerned departments within timelines.
• Instrument Management
Maintain HPLC calibration reports.
Monitor HPLC performance and troubleshooting activities.
Ensure proper maintenance and care of analytical instruments.
Manage HPLC spare parts inventory.
• Investigation & Troubleshooting
Conduct investigation studies as required.
Troubleshoot analytical issues during routine analysis.
Identify root causes and implement corrective actions.
TECHNICAL SKILLS REQUIRED
• Analytical Techniques
HPLC (High Performance Liquid Chromatography)
Method Development
Method Validation
Method Transfer
Analytical Troubleshooting
• Regulatory Knowledge
ICH Guidelines
Regulatory Requirements
GLP (Good Laboratory Practices)
GDP (Good Documentation Practices)
• Documentation
SOP Preparation and Review
Protocol and Report Writing
Investigation Reports
Regulatory Query Responses
EDUCATIONAL QUALIFICATION
M.Sc. (Analytical Chemistry / Pharmaceutical Chemistry / Chemistry)
M.Pharm
Equivalent Life Sciences qualification
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