Analytical Development Officer

Medreich; Bommasandra; On-site; INR 700,000 - 900,000; Full time

Job summary

Medreich is seeking an experienced analytical chemist to lead impurity synthesis and routine testing, including assay, dissolution, RS, GC, IC, and physical parameters, at our Karnataka facility. The role emphasizes method development, AMD reports, and strategy documents, with emphasis on compliance to GLP/GDP and audit readiness for customers and regulators.

You will also handle API qualification, DMF reviews, and change controls, ensure timely incident handling, and manage instrument

Qualifications

• GLP/GDP practices, audit readiness
• Analytical method development and validation
• Documentation and compliance reporting

Responsibilities

• Impurity Synthesis: Perform synthesis of organic, inorganic, and Nitrosamine impurities.
• Routine Analysis: Execute testing for Assay, Dissolution profiles, RS, GC, IC, and physical parameters.
• Method Development: Develop dissolution, Assay, and RS methods, and prepare AMD reports and strategy documents.
• Qualification & Reviews: Conduct analysis related to API Qualification, DMF reviews, Drug-Excipient compatibility, and Forced Degradation studies.
• Compliance & Documentation: Maintain GLP/GDP practices, report online results, write/revise SOPs, and ensure audit-readiness for customers and regulatory agencies.
• Quality Management: Timely handling of Incidents, Deviations, DCRF, and change controls.
• Instrument & Inventory Management: Calibrate analytical instruments, coordinate maintenance, and procure columns, impurities, and chemicals

Job description

Role & responsibilities

• Impurity Synthesis: Perform the synthesis of organic, inorganic, and Nitrosamine impurities.
• Routine Analysis: Execute testing for Assay, Dissolution profiles, Related Substances (RS), GC, IC, and physical parameters.
• Method Development: Develop dissolution, Assay, and RS methods, and prepare comprehensive AMD reports and strategy documents.
• Qualification & Reviews: Conduct analysis related to API Qualification, DMF reviews, Drug-Excipient compatibility, and Forced Degradation studies.
• Compliance & Documentation: Maintain strict GLP/GDP practices, report online results, write/revise SOPs, and ensure audit-readiness for customers and regulatory agencies.
• Quality Management: Timely handling of Incidents, Deviations, DCRF, and change controls.
• Instrument & Inventory Management: Calibrate analytical instruments, coordinate preventive maintenance/breakdown servicing, and procure project-specific columns, impurities, and chemicals

Preferred candidate profile

Immediate joiners or candidates with a short notice period preferred