Grace Katoo

Quality Assurance professional with hands-on experience in In-Process Quality Assurance (IPQA), batch record review, and GMP compliance in pharmaceutical manufacturing. Skilled in QC documentation review, Product Quality Review (PQR) preparation, statistical trend analysis, and batch yield reconciliation. Experienced in sterile manufacturing oversight, environmental monitoring, and supporting deviation and change control processes while ensuring regulatory and quality compliance.

Quality Assurance Associate/In-Process Quality Assurance at Tasa Pharma Ltd (2025-07 – Present)

• Conduct In-Process Quality Assurance (IPQA) oversight during manufacturing and packaging to ensure compliance with GMP and internal quality standards.
• Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for completeness, accuracy, and compliance with Good Documentation Practices (GDP) and ALCOA+ principles prior to batch release.
• Perform QC documentation review, including analytical raw data and Certificates of Analysis (CoA), ensuring accuracy and regulatory compliance.
• Prepare and compile Product Quality Review (PQR) reports, including data compilation and trend analysis for process performance and product quality.
• Conduct batch yield reconciliation and batch yield reporting, ensuring compliance with approved specifications and investigating discrepancies.
• Perform statistical trend analysis to monitor process performance, product quality indicators, and quality system effectiveness.
• Participate in nitrosamine risk assessment and elemental impurity evaluation in alignment with international regulatory expectations and ICH guidelines.
• Review and support vendor qualification documentation, ensuring supplier compliance with company quality standards.
• Support deviation investigations through documentation review, follow-up actions, and tracking of investigation outcomes.
• Participate in change control documentation review and implementation monitoring to ensure controlled and compliant process changes.
• Ensure strict adherence to Standard Operating Procedures (SOPs), GMP requirements, and internal quality systems during manufacturing and packaging operations.
• Monitor operator gowning, hand hygiene, and cleanroom behavior in Grade A and Grade B areas to maintain sterile manufacturing conditions.
• Oversee aseptic material transfers through airlocks into classified production areas, ensuring controlled environmental exposure and proper aseptic techniques.
• Verify that equipment, filters, and containers are appropriately sterilized before and after production to maintain sterility assurance.
• Provide IPQA oversight during filling and sealing of IV bags and ampoules, ensuring correct fill volumes, proper sealing, and prevention of contamination risks.
• Monitor environmental conditions, including air particulate levels, pressure differentials, temperature, and humidity, to maintain controlled sterile environments.
• Perform line clearance checks before and after production to prevent cross-contamination, mix-ups, and material errors.
• Monitor in-process controls, including weight checks, solution clarity, pH, and fill volumes during manufacturing.
• Verify packaging components, labels, and leaflets in the packing area and ensure line boards are accurately updated during production operations.

Quality Control Industrial Attachment at Mac's Pharmaceutical Industry

• Assisted in quality control testing of raw materials, in-process samples, and finished tablet products.
• Performed routine analyses such as weight variation, hardness, friability, disintegration, and pH testing under supervision.
• Supported preparation of reagents and solutions for laboratory testing.
• Participated in maintaining laboratory cleanliness, equipment checks, and calibration support.

BSc in Chemistry – University of Nairobi