Saira Ali
Biotechnology Qc Analyst Ii @SGS
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WORK HISTORY
Biotechnology Qc Analyst Ii @SGS
Mississauga, ON, CA
Role and Responsibilities:> Routinely Designing and Executing projects pertaining to method development, validation, characterization, and method transfer for ELISA, Enzyme Activity, SPR and MSD (Identity, Residual, Potency, Relative Binding Affinity and Kinetics) for GMP and R&D pharmaceutical DS and DP.> Attending regularly scheduled meetings with clients to communicate project findings and outcomes > Writing Protocols, Reports, SOPs, and preparing presentations for clients.>Performing QC testing of DS and DP samples for stability and release.> Generating change controls (CR), handling deviations (OOS, OOE,OOT) and performing investigations.> Working closely with department manager and QA to support the batch release activities while ensuring investigations comply with QMS requirements.> Mentoring colleagues and new employees.
EDUCATION
The Islamia University of Bahawalpur
Bachelor's of Science
PIEAS University
PhD
Bahauddin Zakariya University
Master's degree
Cheeky Scientist Association
Training: Transition from Academia to Industry
Allama Iqbal Open University
B.Ed.
ABOUT SAIRA ALI
A passionate biochemistry professional experienced in analytical method development and validation of drug substances and drug products for enzyme activity, potency, binding affinity and kinetics studies. Hands on experience with techniques including ELISA, Enzyme Activity, Cell Culture, Cloning, Protein Expression, SDS-PAGA and PCR by utilizing and maintaining state of the Art instruments such as Spectrphotomer, PCR, MSD, SPR, HPLC, etc. Managing complex analytical projects and closing out within the required timelines and budget with high quality deliverables. Routinely performing tasks pertaining to designing projects, writing protocols, Reports and SOPs, handling QA activities, CR, Deviations (OOS, CAPA, OOX, OOT) and instrumentation. In depth understanding of cGMP, GLP, GDP FDA and ICHQR Regulation. Proficient in data analysis and communicating projects outcome at each stage to clients. Core Competencies: Soft skills: Problem solving, Communication, Project & People Management, Organization & Time management, Business Acumen, Leadership, Conflict resolution. Transferable skills: Scientific writing, Communication, Documentation, Knowledge of Regulatory compliances, Data analysis. Technical skills: Chromatography (HPLC, LCMS), Protein expression (SDS-PAGE, Western blot), Cloning, PCR, microbiology techniqes. Computer Literacy and Data Analysis: MS Office, Zoom, Google meet, R-Studio, MS Excel, PC-Ord, Unscrambler, Top spin.
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