Execute Analytical Method Development activities of drug products (cosmeceuticals/dermatological/ Sterile/ Oral products) based on QbD principles and regulatory requirements.
Execute Analytical Method Validation activities of drug products as per the regulatory requirements. · Execute routine analytical testing of drug substance and drug products at In-house QC facility.
Technical assessment of drug substance for projects execution ·
Establish In-house systems and procedures to ensure cGLP practices & regulatory requirements for analytical activities at In-house QC facility.
Trouble shooting related to Testing methods, stability studies, test results and designing of additional experimentations as necessary.
Calibration of the Analytical instruments as per the master calibration schedule.
Preparation and review of analytical protocols & reports. Preparation and review of Specifications, Method of analysis procedures and Analytical development reports
Assisting in establishment of In-house infrastructure (Analytical equipment’s qualifications and preparation of SOPs) ·
Preparation of analytical technical documents for dossier/ regulatory submission of projects
Any other specific functional activities defined on case-to-case basis.
