Saira Ali

Background

About Saira Ali

Detail-oriented and results-driven professional with PhD in Biotechnology and over 10 years of experience in managing R&D and cGMP project in academia and pharmaceutical industry. Proven expertise in chemistry, biochemistry, molecular biology and microbiology techniques, methodologies and equipment. Skilled in documentation and regulatory affairs with deep knowledge of ALCOA+, pharmacopeias, cGMP, ICH, WHO and FDA regulations. Adept at collaborating and communicating with cross-functional teams to drive continuous improvement. KEY COMPETIENCES AND ACHIEVEMENTS Analytical Quality Control and R&D: o Led method development and validation for purity, identity, dose response and stability of drug products and APIs. o Performed QC analytical testing of manufacturing batches, clinical trial material and vaccines while adhering to cGMP guidelines, following relevant Pharmacopeias and/or client methods. Equipment Validation/Qualification: • Leveraged techniques proficiency in HPLC, Osmolality, TOC, Conductivity, UV-Vis, ELISA, SDS-PAGE, Western Blot, Cloning, Transformation, PCR, BCA, and Bradford to execute analytical testing. • Participated in analytical equipment validation, qualification (IQ/OQ/PQ) and calibration operations, and filed documentation for audits as per the regulatory requirements. Regulatory Compliance/Auditing: • Participated in internal & external audits, responded to quality-related queries, and provided quality documents indicating adherence to FDA, Health Canada regulations as well as client SOPs and guidelines. Quality Assurance/ Quality Management/Document Control: • Authored and compiled SOP, Protocols, Reports, and QC Quarterly Reports and Annual Trend Analysis. • Led Change Controls, Deviations, Complaints, CAPA, RCA to support the timely closure of NCRs/CAPAs Software Expertise/Data Analysis: • Google Suite, Excel, Minitab, R-studio, LIMS, Track Wise Digital, Compliance Wire, KneatX and Veeva Vault