Azfar Abbas
Pharmaceutical and Biotech Professional
- Role
- Quality Consultant at Lupin Pharmaceuticals
- Location
- Fort Lauderdale, FL, US
- LinkedIn followers
- 500 followers
About Azfar Abbas
Over 20 years of experience in the pharmaceutical and biotech industries with expertise in Quality Assurance, Quality Control, Analytical Method and Process Development and Validation, Manufacturing Operations, CDMO Management, and Regulatory Compliance. Proven track record of optimizing manufacturing processes, leading teams through product development, and executing comprehensive CMC strategies. Adept at managing deviations, CAPAs, complaints, change controls, technical review of manufacturing & testing documents, lab and manufacturing investigations, and GMP audits. Successfully transitioned multiple R&D organizations to full cGMP compliance, enabling clinical material manufacturing, release testing, and regulatory audits. Well-versed in handling complex products, including drug/device combinations and human cells, tissues, and cellular and tissue-based products.Core Competencies include:CMC Development & Manufacturing Strategy | Analytical Method Development and Validation |Process development and validation |Quality Assurance/Control |Vendor and CDMO Management|Stability Program Management |Clinical Material Manufacturing | Method Transfer | Laboratory/Manufacturing Investigations |Internal/External Audit | QMS | GMP, GLP, ICH Guidelines Compliance | ISO 13485, FDA Part 820 |
Experience
Quality Consultant
Jun 2025 — Present · Coral Springs, FL, US
Education
The City University of New York
Doctor of Philosophy (Ph.D.), Biochemistry
1996 — 1999
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.