Jisna Chacko

Key Responsibilities & Achievements

• Performed routine and non‑routine analysis of pharmaceutical, medical device products, including wound dressings.
• Performed inspections of sterile medical devices, adhering strictly to ISO 13485:2016 standards and cGMP requirements
• Conducted chemical, microbiological, analytical testing using approved methods & GLP/GMP standards.
• Operated, calibrated, maintained laboratory instruments including MP‑AES, UV‑Vis, FTIR, Karl Fischer, HPLC, GC, titration equipment (silver & calcium).
• Interpreted analytical results, identified issues, and performed troubleshooting to ensure data accuracy and reliability.
• Completed microbiological environmental monitoring within the manufacturing plant.
• Validating cleanroom environments (ISO Class 5-8) and monitor sterilization parameters to ensure product sterility assurance.
• Managed equipment calibration schedules, maintenance activities, defect reporting to QC leadership.
• Ensured laboratory conditions were monitored and maintained in compliance with quality & safety requirements.
• Maintained analytical sample logs, results logs, and daily spreadsheet updates with strong attention to data integrity.
• Generated, reviewed, approved, released Certificates of Analysis (CoA) & Certificates of Conformance (CoC).
• Supported routine product release & product registration activities.
• Received, reviewed, interpreted external laboratory test reports.
• Managed daily QC inbox activities, ensuring timely responses and workflow continuity.
• Investigated non‑conformities (NC), supported CAPA activities, authored technical reports including OOS investigations.
• Maintained & archived product‑related documentation to ensure compliance and traceability.
• Approved & released controlled documents in accordance with quality management system requirements.
• Worked safely in accordance with EHS policies, COSHH requirements, and PPE standards.
• Performed risk assessments and contributed to continuous improvement of laboratory safety practices.
• Ensured strict adherence to data integrity and good documentation practices (GDP).
• Utilised LIMS and quality management systems for sample tracking, documentation, and reporting.
• Collaborated effectively with cross‑functional teams while also working independently to meet deadlines.
• Maintained 6S housekeeping standards to ensure a clean, organised, and safe laboratory environment.
• Demonstrated strong analytical, problem‑solving, and communication skills in daily laboratory operations.
• Supported method validation and method transfer activities as required.
• Proficiently used Microsoft Office applications for reporting, trending, and data analysis.

• Performed Super Critical Fluid Chromatography (SFC) - Normal Phase Purification of Chiral & Achiral samples. Worked on more than 2000 samples in small scale as well as in bulk scale.
• Worked on Screening, Method Development, & Purity of samples
• Troubleshooted Analytical Instruments
• Carried out High Performance Liquid Chromatography (Prep HPLC) - Reverse Phase Purifications
• Worked on Method development in SFC and HPLC
• Performed Liquid Chromatograph - Mass Spectrometry (LC-MS) -Mass Identification of compounds.
• Experience in GLP and GMP lab environment.
• Gas Chromatography -Separation & analysis of compounds
• Nuclear Magnetic Resonance-Spectroscopy (NMR Spectroscopy)
• Infrared Spectroscopy (IR Spectroscopy)
• Calibrated and maintained all laboratory equipment for accurate testing outcomes.
• Communicated analysis results to stakeholders for effective product formulation.
• Created spreadsheets and other forms of documentation to accurately record and calculate analytical results.
• Updated databases with current, accurate results for continued analysis.
• Implemented environmental control processes for enhanced testing validity.
• Maintained standardized testing conditions for reliable project outcomes.
• Collected and analysed samples to recognize toxic substances.
• Collaborated with scientists and engineers on research and system maintenance.
• Managed laboratory conditions for toxic and unstable drug testing
• Handled high volume calls to address scientist-chemist inquiries and concerns.
• Quickly learned and applied new skills to daily tasks, improving efficiency and productivity.