Quality Control Regulatory Compliance
Resume:
AFSANEH OSHLI
******.*****@*****.***
www.linkedin.com/in/afsaneh-oshli
Professional Summary
Detail-oriented and dedicated Quality Control (QC) Specialist with over 8 years of experience in pharmaceutical
laboratories. Skilled in analytical testing (HPLC, UV-Vis spectrophotometry, dissolution tests, and wet chemistry
techniques) and microbiological assays, with a strong foundation in cGMP/GMP, GXP, FDA CFR 211, method
validation, and regulatory compliance (USP, EP, ICH). Experienced in managing laboratory inventories, preparing
reagents, and maintaining equipment. Adept at cross-functional collaboration, deviation investigations, CAPA
implementation, and environmental monitoring. Recent hands-on exposure in Canadian pharmacy practice
demonstrates adaptability to local procedures and standards.
Work Experience
Microbial QA/QC Supervisor — Homa Pharmed, Tehran, Iran (2023–2025)
Homa Pharmed is a pharmaceutical company, specializing in the manufacturing and distribution of high-quality
healthcare products.
Supervised all microbiological QA/QC activities in cleanrooms, water systems, and production
areas per USP and GMP standards.
Performed microbial risk assessments, deviation investigations, and implemented CAPA plans.
Managed environmental monitoring, bioburden, endotoxin (USP <85>), and microbial limits
testing (USP <61> & <62>).
Developed and validated test methods; reviewed equipment calibration and documentation logs.
Acted as liaison between QA and production to support continuous improvement.
Maintained laboratory inventories and prepared reagents and solutions for daily QC activities.
Conducted product stability testing to ensure ongoing microbial quality over shelf-life.
Quality Control Specialist — Saman Darou, Tehran, Iran (2019–2023)
Saman Darouye Hashtom is a biotechnology company, specializing in the production of recombinant human Factor
VIII for hemophilia Treatment.The Company also focuses on monoclonal antibody-based oncology drugs.
Conducted QC testing on finished products, raw materials, and process intermediates using HPLC,
UV-Vis spectrophotometry, and potency assays.
Performed ELISA and qPCR to monitor HCPs and residual DNA in biopharmaceutical products.
Conducted LAL endotoxin testing, water analysis, and cleanroom monitoring.
Gained experience in handling a wide range of laboratory equipment, including dissolution
apparatus, pH meters, and balances.
Prepared and maintained SOPs, CoAs, and documentation for regulatory compliance.
Collaborated with R&D and QA for analytical method validation and product development.
QC Laboratory Analyst — Zistdaru Danesh, Tehran, Iran (2014–2019)
Zist Darou Danesh is a pharmaceutical company specializing in the research, development, and production of
biopharmaceutical products.
Conducted chemical and microbial assays according to USP/EP.
Performed HPLC analysis, dissolution tests, and UV-Vis spectrophotometry for assay and impurity
profiling.
Performed daily verification of balances, pH meters, and purified water TOC & Conductivity.
Prepared reagents, solutions, and maintained cleanliness and organization of laboratory
equipment.
Verified and recorded all laboratory data loggers (e.g., temperature, humidity, water TOC) on a
daily basis.
Participated in new method development and analytical troubleshooting projects.
Supported internal audits and inspections through robust documentation and test record
management.
Education
M.S. in Microbial Biotechnology — Iran University of Science and Technology, Tehran, Iran (2011–2013 )
Technical skills
Instrumentation: HPLC, UV-Vis, dissolution apparatus, pH meters, balances, incubators,
autoclaves
Microbiology: Bioburden, Sterility, LAL/Endotoxin, Environmental Monitoring
Molecular/Protein Techniques: ELISA, SDS-PAGE, qPCR, Western Blot
Software: Microsoft Word, Excel, PowerPoint, LIMS
Compliance: cGMP/GMP, GXP, FDA CFR 211, GLP, ICH, USP, EP, CAPA, deviation investigation,
ALCOA+
Training and Certificates
Good Manufacturing Practice (GMP) & Good Laboratory Practice (GLP)
Microbial Environmental Monitoring & Cleanroom Contamination Control
Deviation Management & CAPA Implementation
Pharmaceutical Water System Maintenance (PIC/S, WHO, ISPE standards)
Pharmaceutical Microbiology Internship – IINS (Switzerland Collaboration)
Additional Information
Eligible to work in Canada – No work sponsorship required
Recent volunteer Compounding Pharmacy Assistant experience in Ontario
References available upon request
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