Job Description

• 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.