Analytical R&D

Job Responsibilities

• To ensure the daily operations of analytical lab in ARD Department.
• Responsibility to analytical method development, validation, and routine testing.
• Manage release and stability testing of raw materials, in-process, and finished products on time.
• Preparation of validation protocols and reports as per USFDA, EMA and ICH guidelines.
• Ensure the lab instrument calibrations and maintenance as per the in-house protocol.
• Responsible for implementation of GLP activities in ARD lab.
• Responsibility to verify the all log books on daily basics.
• Preparation standard operating procedures in ARD Lab.
• Responsibility to ensure the sample management system in ARD Lab.
• Responsibility to ensure the lab cleanness in ARD lab.
• Initiation and closing of incidents, VIRs and Change controls in ARD lab.
• Ensure the qualifications of lab instruments in ARD lab.
• Responsibility to coordinate with the vendors to resolve the instrument related issues.
• Perform the development, validation, stability and support analysis on priority basis.
• Preparation of specification, test methods, standard testing procedures in ARD lab.
• Responsibility to assign the AR Numbers to testing samples from FRD or Third party.
• Responsibility to loading and withdrawal of stability samples as per the protocol.

Skills Required

Validation, stability testing