Maryam Salili

PharmD with over 10 years of progressive experience in pharmaceutical manufacturing, quality systems, hospital pharmacy, and clinical research. Proven expertise in pharmaceutical production, cGMP compliance, validation, quality control, process optimization, technical documentation, and regulatory standards. Adept at supporting manufacturing operations, investigating deviations, maintaining data integrity, and driving continuous improvement through collaboration with multidisciplinary teams.

Strong scientific background in pharmaceutical sciences with excellent analytical, communication, and problem-solving abilities. PEBC evaluated and committed to delivering high-quality pharmaceutical products while ensuring patient safety and regulatory compliance.

Manufacturing Technician - Apotex Inc. - Toronto, Canada

(2026-04)

• Completed and reviewed batch records, logbooks, and electronic documentation, ensuring data integrity and MWS compliance, accurate recordkeeping, and compliance with regulatory and quality standards.
• Performed equipment cleaning, line clearance, in-process inspections, and quality checks, supporting validation activities and maintaining inspection-ready manufacturing areas using 5S principles.
• Collaborated with Quality Assurance, Quality Control, Warehouse, and Engineering teams to investigate deviations, implement corrective actions, troubleshoot production issues, and support continuous process improvement initiatives.

Clinical Trial Coordinator & Pharmacovigilance specialist - Iran University of Medical Science - Tehran, Iran

(2020-01 - 2026-01)

• Coordinated clinical studies, ensuring 100% protocol adherence and regulatory compliance for Drug Substance manufacturing.
• Collaborated with physicians, pharmacists, and healthcare teams to support study implementation and patient safety and advance medical affairs
• Developed and implemented standard operating procedures to ensure compliance and efficiency in research protocols
• Integrated theoretical knowledge with practical clinical practice to address complex patient care challenges in pharmaceutical research
• Oversee thorough adverse event reporting and Clinical operations processes
• Managed and maintained the electronic Trial Master File (eTMF) system, ensuring data integrity and regulatory compliance for clinical research.
• Contributed to clinical development and Technical standards strategies, advancing research initiatives and therapeutic advancements up to 20%.
• Leveraged ich-gcp guidelines to ensure data integrity and compliance in clinical research projects

Hospital Pharmacy Manager - Iran University of Medical Science - Tehran, Iran

(2014-03 - 2019-03)

• Managed pharmacy operations in a high-volume hospital environment to enhance healthcare delivery.
• Achieved and exceeded sales targets by 20% through strategic planning and execution in the pharmaceutical sector
• Oversaw medication inventory, ensuring compliance and supporting operational accountability.
• Educated healthcare teams on pharmaceutical products, medication protocols, and treatment practices using communication tools.
• Trained over 20 staff members, streamlining workflows and enhancing team efficiency.
• Built collaborative relationships with physicians, pharmacists, and healthcare staff.

IPQC coordinator - Delta Daru Pharmaceutical Company - Tehran, Iran

(2008-11 - 2014-02)

• Coordinated daily quality control activities to ensure manufacturing operations complied with cGMP, GMP, and company quality standards and troubleshot production equipment to maintain high standards of pharmaceutical quality.
• Reviewed and verified batch production records, SOPs, logbooks, and manufacturing documentation and computer applications to ensure accuracy, completeness, and regulatory compliance.
• Assisted with deviation investigations, root cause analysis, CAPA implementation, and change control documentation to maintain quality systems.
• Coordinated sampling activities and collaborated with Quality Control laboratories for analytical testing and timely release of production batches.
• Maintained data integrity by accurately documenting production activities in electronic quality management systems and laboratory databases.
• Participated in equipment qualification, process validation, cleaning validation, and continuous process improvement initiatives.
• Collaborated with Manufacturing, Quality Assurance, Engineering, Warehouse, and Supply Chain teams to support efficient production operations.
• Assisted with material handling, inventory reconciliation, warehouse coordination, and GMP-compliant storage of raw materials and production supplies.
• Trained production personnel on Good Manufacturing Practices (cGMP), SOPs, Health & Safety (HSE), documentation practices, and quality procedures.
• Participated in internal audits and regulatory inspections, ensuring readiness and compliance with pharmaceutical manufacturing standards.
• Applied 5S and Lean Manufacturing principles to maintain clean, organized, and inspection-ready production areas.

PhD Candidate - Pharmacognosy - Tehran University of Medical Sciences (2021-01)

Master of Pharmacy (Pharm D) - Pharmacy - Azad University of Medical Sciences (2001 - 2006-11)