Quality Assurance Control

Qualified Pharmacist with ** years of hands –on experience in research,analysis,quality control and quality assurance with pharmaceutical and testing laboratories settings. Seeking a challenging role to apply my deep knowledge of microbiology and pharmaceuticals towards driving innovation,ensiring compliance and optimizing processses for enhanced patient care and scietific advancement.

SKILLS

Regulatory Knowledge:Understanding Microbiology Knowledge

Quality Management System(QMS) Aseptic Technique

Analytical Skills Microbial Identification

Auditing Skills Environmental Monitoring

Project Management Microbial Enumeration

Document Control Sterility Testing

Training and Development Bacterial Endotoxin Testing

Ethical Conduct Method Validation

PROFESSIONAL EXPERIENCE

Assistant Manager Quality Assurance/Microbiology

PAKISTAN DRUGS TESTING AND RESEARCH CENTER (PDTRC), LAHORE March 2015 to date

Responsible in developing, implementing, and maintaining QMS to ensure compliance with regulatory standards (e.g., Good Laboratory Practices (GLP), WHO Technical Reference Standard 957, ISO standards, Good Documentation Practices (GDP).

Responsible in maintaining accurate and detailed records of quality assurance activities, including audits, inspections, and corrective actions.

Responsible for investigation and processing Deviations,Out of Specifications,Identification & reporting of Non Conformances/ and Out of Trends QC events.

Developed strong technical skills in various microbiological testing on pharmaceutical products, including microbial enumeration, identification, and sterility testing,Bacterial endotoxin testing,Microbiological assays, Bioburden test and water testing including pathogens identification, ensuring compliance with regulatory requirements.

Developed and validated microbiological testing methods, improving efficiency and accuracy of testing procedures.

Achievements in PDTRC

During my duties in PDTRC as AM Microbiology/Quality Assurance, I have defended three audits, one by USP-PQM(United States Pharmacopeia-Promoting Quality of Medicines) and two by WHO(WORLD HEALTH ORGANIZATION) and no major observation was found by auditor on my working, I gained Letter of Appreciation for sucessful execution of audit.

I have also participated in proficiency testing plan. I have done interlaboratory comparison.

I have also involved in Quality Assurance in conducting PNAC audit. I have done excessive documentation work for QMS & successfully defended the ISO audit including Surveillance audits and full Assessments audit of ISO-17025:2017.

I have also served duty in Maintenance of Bioequivalence lab and prepared excessive documents i.e, Preparation of SOPs, Study Protocol, Bioanalytical method validation, volunteer's consent form and others. I have also defended DRAP's Audit/Inspections and achieved successful Certification for my organization to act as Bioequivalence Center and Bioanalytical Laboratory.

I have also participated in microbiological testing of Medical devices of Byonyks Pvt Ltd as per ISO 11737-1, ISO 11737-2 Standards. Byonyks is the world’s first biomedical device innovation startup focused on designing affordable healthcare devices using state-of-the-art medical technology for Peritoneal Dialysis(Bloodless) Machines.I have tested samples as per ISO Guidelines and performed Sterility test,Bioburden test, Identification of specific pathogens,endotoxin testing,Aging Study protocol and Cleaning validation protocols as per ISO testing Protocols successfully.

Assistant Manager Quality Assurance ARAF PHARMACEUTICALS, LAHORE

May 2014 to Feb 2015

Conducted quality assurance audits to ensure compliance with established procedures and standards.

Developed, implemented and maintained quality control systems for the organization.

Evaluated new products for adherence to design specifications, industry standards and customer requirements.

Senior officer microbiologist SURGE LABORATORIES, SHEIKHUPURA

April 2012 to April 2014

Conducted quality assurance audits to ensure compliance with established procedures and standards.

Developed, implemented and maintained quality control systems for the organization.

Senior officer microbiologist SURGE LABORATORIES, SHEIKHUPURA

April 2012 to April 2014

Developed, validated and implemented new microbiological testing methods to ensure quality control of products.

Trained junior microbiologists on proper aseptic techniques and laboratory protocols.

Performed environmental monitoring to assess the cleanliness of manufacturing areas.

Generated SOPs for all activities related to microbiology lab operations.

Evaluated new technologies related to microbiological testing for Cosmetics and their suitability in our laboratory setup

Microbiologist/QC Analyst ENGLISH PHARMACEUTICAL INDUSTRIES, LAHORE

May 2009 to Nov 2011

Performed accurate and timely data entry for QC records.

Conducted regular inspections of incoming materials, components, and finished products.

Reviewed inventory levels of raw material, packaging components, chemicals. used by the Quality Control department

Actively participated in GMP Inspections.

EDUCATION

Pharm-D [Doctor of Pharmacy] (2004-2009) University of the Lahore

Relevant Courses: Quality Control,Quality Assurance,Pharmaceutical Formulations,Bio equivalence.

CERTIFICATIONS/TRANINGS

Biological Testing Laboratories:Biosafety and Biosecurity by Prof.Gerad (USA) in DTL Lahore 2023

Training Orientation in Drug Testing Laboratory, Lahore Nov 7-20, 2023

Certified training on Potiometric analysis,Titrimetric analysis,Water content,Los on Drying,Loss on ignition,Flame photometer,Atomic absorption Spectrophotometer,Optical rotation,Development & review of Quality Management System as per ISO 17025-2017 and Laboratory Information File(LIF) as per WHO Technical report series (TRS No.957) in PQCB, 01, Lahore Oct 29-Nov 2018

Certified training on Quality Management,Failure Mode Effect Analysis (FMEA), Method,Change Control Manangement, Handling of Deviations and DATA Integrity in PDTRC Oct 31, 2018

Training on Preparation for External Audits by Hari Ramanthan & Nadeem Alamgir Jun 21, 2018

Training on HPLC Basic Theory and hands on by Dr.Yanga & Mr.Azmat Hayat May 05, 2017

Training on LC-MS MS By Khalid Ghaffar (Business Development Manager Waters Sep 30, 2021

WHO Pre Qualification Requirements by Hari Ramanthan Oct 10-12, 2016

REFERENCES

Available upon request.

UMM-E-FARWA

Manager Quality Assurance/Microbiology

+92-305******* # www.linkedin.com/farwa.farwa # *********@*****.***

Contact this candidate