Job Description

• Conduct analytical method validation for investigational drug products using HPLC, ensuring compliance with ICH guidelines (Q2) and USP/BP standards to maintain high-quality results.
• Perform stability testing, both accelerated and long-term, to assess product shelf-life and degradation profiles, providing crucial data for product development and safety evaluations.

Job Description

• Gained hands-on experience in aseptic processing and lyophilization of biological products under strict sterile environment protocols. (GMP compliance)
• Conducted container closure integrity testing (CCIT) and 100% visual inspection to ensure product sterility and safety.
• Assisted in the drug registration renewal process by performing gap analysis between historical dossiers and updated documentation.
• Conducted quality control of primary and secondary packaging, including sample size calculation following ISO standards, and performed inspections according to SOPs.

Job Description

• Prepared a quality risk assessment document for skip testing of products, analyzing historical data to optimize testing frequency without compromising quality.
• Established a statistical process control chart template for product quality review (PQR) to improve trend analysis.
• Performed physicochemical testing of raw materials and finished products using HPLC and other analytical instruments to ensure adherence to specifications.