Mahwish Shahab

Results-driven Pharmaceutical Microbiologist with 9+ years of experience in QC microbiology within GMP-regulated pharmaceutical environments. Ex-Assistant Manager QC Microbiology at Sanofi-Aventis Pakistan. Expertise in environmental monitoring, sterility testing, bacterial endotoxin testing, and regulatory compliance (FDA, WHO, EMA).

Strong track record in audit preparation, CAPA management, risk analysis, and contamination control strategies. Currently undergoing international training in Quality Management System (QMS).

Assistant Manager – QC Microbiology - Sanofi-Aventis Pakistan Ltd. - Karachi, Pakistan

(2016-05 - 2025-07)

Promoted to Asst. Manager in September 2022

• Led microbiological testing and release of raw materials, finished products, and packaging materials per USP, EP, BP standards.
• Managed environmental monitoring programs for sterile and non-sterile areas using settle plates, contact plates, swab testing, active air sampling, and particle counting.
• Performed Bacterial Endotoxin Testing (BET/LAL) for raw materials, finished products, and WFI per USP <85>.
• Conducted sterility testing of injectable products per USP <71> using membrane filtration and direct inoculation methods.
• Validated disinfectant efficacy for cleanroom decontamination per EU GMP Annex 1; executed microbial limit testing per USP <61>/<62>.
• Prepared and reviewed GMP documentation including SOPs, OOS/OOT investigations, deviation reports; participated in FDA, WHO, and corporate audits.
• Conducted risk assessments, gap analysis, and managed operator qualification and gowning assessments for classified areas.

Microbiologist - Daw Laboratories (Pvt.) Ltd.

(2014-04 - 2014-10)

• Performed water system monitoring (purified water & WFI), isolated and identified environmental and product isolates, maintained laboratory inventory and calibration records.

Research Microbiologist (Short-term) - PCSIR Laboratories Complex, Karachi - Karachi, Pakistan

(2015-01 - 2015-01)

• Conducted microbiological analysis of food products including total viable count, coliform count, and pathogen screening.

M.Sc. - Microbiology - University of Karachi (2011)

B.Sc. (Hons) - Microbiology - University of Karachi (2006)