Quality Control Analyst QC/QA in GMP Environments
Resume:
MAHTAB YARMOHAMMADI
Quality Control and Quality Assurance Specialist with over five years of experience in GMP/GLP regulated pharmaceutical and cosmetic manufacturing environments. Strong background in analytical chemistry, QMS, investigations, CAPA, documentation, and regulatory compliance. Adept at method development, data integrity, and cross functional collaboration. Seeking a challenging QC role contributing to the production of safe, compliant, and high quality products.
Summary of Qualification
Extensive knowledge of GMP, GLP, GDP, and pharmaceutical quality control principles
Strong understanding of QMS processes: change control, deviation management, investigations, CAPA
Skilled in drafting and reviewing deviations, investigations, and change controls
Experienced in reviewing Stability data, APQRs, Master Batch Records, and quality complaints
Proficient in FTIR, Karl Fischer, UV Vis, TLC, HPLC, UPLC, GC, and Dissolution testing
Skilled in method development, method validation, and analytical instrument maintenance (Empower)
•Strong wet chemistry skills: solution preparation, titrations, pH, serial dilutions, viscosity, LOD
Advanced computer proficiency: LIMS, SAP, TrackWise, eDMS, SharePoint
Experienced in SOP writing, technical documentation, and regulatory compliance
Excellent analytical thinking, attention to detail, and ability to interpret complex datasets
Strong communication, teamwork, and problem solving skills
PROFESSIONAL EXPERIENCE
Quality Control Analyst, The Estée Lauder Companies Inc., Toronto, Canada (September 2023-Present)
Performed daily, weekly, and monthly verifications of balances, pH meters, and viscometers; resolved equipment troubleshooting issues, and ensured the quarterly maintenance of HPLC/UPLC instruments.
Demonstrated expertise in adhering to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards. Conducted a variety of quality tests, including Drop point, Break point, Viscosity, Specific Gravity, % water by Karl Fischer, % Solids, TOC by TOC analyzer, Penetration test, and pH test.
Conduct routine and non-routine analysis of mass and finished goods and report results, using instrument such as UPLC, HPLC, GC through Empower software.
Rigorously followed Standard Operating Procedures (SOPs) and the monographs Pharmacopeia to perform all tests, meticulously documenting results in accordance with Good Documentation Practices.
Utilized LIMS and SAP systems to log test results and release bulk quantities following successful quality checks.
Undertook Phase I investigations and lab inquiries in cases of Out of Specification results (OOS), promptly reporting findings to supervisors and managers.
Conducted OOS/OOT investigation, deviation reports, change control and CAPA to ensure data integrity and compliance, and generated comprehensive Out of Specification (OOS) reports and deviations in strict accordance with SOPs.
Updated of forms, method validations, and new procedures and SOPs any other QC related documents.
Maintained accurate documentation, reports and laboratory records in accordance with GMP standards.
Maintained open lines of communication with Technical Services/Group leaders, QA and QC Analysts/Managers, document coordinators, Product Compliance Specialists, and the R&D team to address quality issues and improvements. Promptly communicated with various shifts regarding quality concerns and follow-ups.
Ensured the QC Laboratory is in a ready state of compliance for internal and external audit.
Quality Control Specialist, Chemist Inc., APOTEX Inc.,Toronto, Canada (August 2022- September 2023)
Conducted comprehensive analysis of pharmaceutical raw materials, in-process samples, finished products, and stability samples using a variety of analytical instruments and established procedures
Used Dissolution apparatus, UV/Vis, HPLC, KF, FTIR for testing samples
Documented, interpreted, and compiled analytical data in accordance with SOPs and good documentation practices
Entered and managed analytical results in the laboratory information management system (LIMS), and maintained data integrity (ALCOA)
Performed method transfer and verification activities to ensure accurate and reliable analytical results
Recognized and investigated out-of-specification and out-of-trend (OOS and OOT) results, utilizing root cause analysis techniques and implementing corrective and preventive actions (CAPA) as necessary
Conducted routine maintenance, calibration, and qualification of laboratory equipment, adhering to calibration schedules and GMP requirements
Collaborated with cross-functional teams to ensure timely completion of quality control testing and release of GMP-compliant products
Maintained compliance with regulatory guidelines, industry standards, and safety requirements
Reviewed and revised SOPs related to quality control testing, method validation, and stability studies
Quality Assurance Associate, Galderma Canada- Toronto, Canada (September 2021 – August 2022)
Participated in client audits, preparing audit agendas, questionnaires, and reports
Reviewed raw data, identified observations, and facilitated the completion of corrective and preventive actions for activities related to the importation and distribution of RX, OTC, natural health products, and medical devices.
Prepared and presented required documentation for Health Canada audits and regulatory inspections to ensure regulatory compliance
Managed the quality release process for finished product distribution, ensuring compliance with quality standards and regulatory requirements
Reviewed and updated Technical Quality Agreements and Drug Establishment Licenses, to ensure compliance of activities and products with Health Canada regulations
Resolved quality issues, including customer complaints, returns, and shipping/storage conditions
Conducted thorough deviation investigations, employing root cause analysis techniques and implementing effective CAPA strategies
Assessed and provided disposition for returned products based on quality assessments and compliance evaluations
Maintained adherence to relevant GXP regulations to ensure compliance throughout all quality assurance activities
reviewined Stability and APQR, Master Batch Production Records, Quality complaints required by regulatories and worked with the clients to complete reports prior to submit to Health Canada
Organized and scheduled client audits, maintained audit binders and records, reviewed audit reports and responses, and performed SOP reviews and updates
Quality Control Analyst, Chemistry Department- International Sturgeon Research Institute (2012-2021)
Designed experiments for HPLC analysis
Assisted with developing, revising, and reviewing SOPs, USP, EP, BP, and protocols
Performed Research on new reagents, new biological sources, and method validation to prepare to summarise from manufacture
Developed method validation/ transfer for new products
Perform IQ, OQ, and PQ for new equipment and Calibrated lab equipment according to established procedures and Updated and maintained the instruments Log(s) on a daily basis
Evaluated results for potential OOS/OOTand implemented appropriate CAPA and change control
Documented the results of experiments based on GDP/ALCOA
Requested and logged samples for QC testing and retention.
Reviewed documents, and calibration of instruments, to ensure method accuracy and precision
Assisted QA managers with method transfer activities
Initiated deviation reports and conducted investigations as necessary
EDUCATION/PROFESSIONAL DEVELOPMENT
Pharmaceutical Quality Assurance and Quality Control (Postgraduate Diploma)- August 2021-June 2022
Academy of Applied Pharmaceutical Sciences College, Toronto, Canada
PhD of Biology
Gorgan University of Agricultural Sciences and Natural Resources, Gorgan, Iran (equivalent to a PhD of Biology, as determined by World Education Services in Toronto, ON)
M.Sc. of Biology
Gorgan University of Agricultural Sciences and Natural Resources, Gorgan, Iran (equivalent to a M.Sc. of Biology, as determined by World Education Services in Toronto, ON)
B.Sc. of Biology
Tehran University, Tehran, Iran
(Equivalent to a B.Sc. of Biology, as determined by World Education Services in Toronto, ON)
VOLUNTEER ACTIVITIES
Volunteer at Fracture Clinic (Michael Garron Hospital), ON (June 2019- August 2019)
REFERENCES AVAILABLE UPON REQUEST
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LinkedIn profile: https://www.linkedin.com/in/mahtab-yarmohammadi/
North York, Ontario
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