Asma Khalid

Contributed to the establishment and implementation of the company’s Quality Management System (QMS)

-Developed and maintained the Quality Manual, Quality Plan, SOPs, procedures, forms, and controlled quality documentation.

-Established and supported document control and QMS documentation accordance with GMP/GDP principles.
-Developed and implemented quality processes covering Risk Management, CAPA, Deviations, Change Control, Internal Audits, Data Integrity, GDP/GMP, and Batch Reconciliation.

-Supported supplier and contractor qualification, quality agreements, external audits, and ongoing quality oversight.
-Conducted and supported internal and external audits, including audit planning, checklist preparation, evidence review, findings, CAPA follow-up, and closure.

-Supported the organization’s inspection and audit readiness through controlled documentation, quality records, risk-based monitoring, and continuous improvement activities.

• Use the ERP system (Epicor) for lab work and to create certificates of analysis (COA) for the released materials.
• Writing and reviewing SOPs, protocols, trend reports, and methods of analysis which comply with USP and EP.
• Distributing QC work for the team, and checking the results.
• Reviewing all the data.
• Coordinating with other supervisors.
• Provided training and mentorship to junior analysts, enhancing team capabilities and performance.
• Led and directed team members in completing development-related tasks by initiating projects, driving resolution of issues and holding members accountable for results.
• Prepare a stability study plan for two conditions (Accelerated, Long term).
• Prepare the specification and test report, and update it when work is needed.

• Analysis of water samples and conducting further tests such as TOC, conductivity, pH, chlorine test, and TDS, and comparing the results with the acceptance criteria, notifying the supervisor if any deviations are present.
• Can use Shimadzu and Agilent HPLC to analyse finished and stability batch tests.
• Can use Teledyne Dissolution and Teledyne TOC.
• Can use the Shimadzu UV spectrophotometer.
• Perform the calibration for HPLC, UV spectrophotometer, melting point, and polarimeter.
• Perform the daily calibration for all balances, pH meters, and conductivity meters.
• Well knowledgeable in safety, GMP, and GLP requirements.
• Can use all microbiology lab equipment, such as the autoclave, incubators, and Vitek identification system.
• Conduct all microbiology tests for water and finished products, and prepare all types of required media.
• Conduct the method validation studies.
• Conducted chemical and biological tests on drinking water, waste water and sludge samples to analyse findings.
• Managed laboratory inventory, ensuring timely procurement of reagents and supplies critical for uninterrupted research activities.
• Analysis of packaging materials, such as boxes and leaflets.
• Handling the reference standards in the lab.
• Conduct the method validation studies.
• Well knowledgeable about growth promotion tests, media preparation, environmental tests, TAMC, and TYMC.
• Handling the chemical reagents store for the lab and controlling the stock consumption and issuing.