Lathika Gopinath
Experienced Quality Assurance Leader - QMS/ Risk Management/Vendor Management/QA for Mfg /QA for QC /QA Raw materials / Method Transfer/Technology Transfer/ Quality Operations
- Role
- Associate Director, Qa-cmc at Aerogen Pharma
- Location
- Mountain View, CA, US
- LinkedIn followers
- 500 followers
About Lathika Gopinath
Experienced leader in quality assurance and analytical sciences functions working with different dosage forms and delivery systems, such as tablets, capsules, and inhalation products for small molecules and biologics. I am a Certified Quality Auditor (CQA) with expertise in cGMP compliance, supplier management, raw materials management, combination products, deviation, CAPA, and risk management, product complaints, batch records, product release, and SOPs. I have successfully managed and hosted audits and audited suppliers, ensuring regulatory compliance and quality standards. I have also led projects from the initial stages to successful closure, collaborating with cross-functional teams and stakeholders. My mission is to deliver safe and effective products to patients, while maintaining excellence and integrity in my work.
Experience
Associate Director, Qa-cmc
Apr 2025 — Present · San Mateo County, CA, US
Education
KJ Somaiya College of Science
Bachelor of Science - BS
Skills
- Technology Transfer
- Validation
- R
- Corrective and Preventive Action (Capa)
- Hplc
- Gmp
- Good Laboratory Practice (Glp)
- Drug Development
- Biotechnology
- 21 Cfr Part 11
- U.s. Food and Drug Administration (Fda)
- Standard Operating Procedure (Sop)
- Formulation
- Analytical Chemistry
- V&V
- Drug Delivery
- Glp
- Verification and Validation (V
- Pharmaceutical Industry
- Sop
- Fda
- U.s. Title 21 Cfr Part 11 Regulation
- Capa
- Chromatography
- Change Control
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