Sirisha Dandu
Quality Assurance Packaging Documentation Specialist-1 @Cipla
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WORK HISTORY
Quality Assurance Packaging Documentation Specialist-1 @Cipla
Fall River, MA, US
Ensured compliance with SOPs and GMP through rigorous in-process quality checks during packaging operations. • Conducted thorough batch record reviews, maintaining accuracy and completeness while flagging deviations for investigation. • Managed deviation documentation and CAPA implementation, fostering a culture of continuous improvement. • Oversaw logbook and cleaning record checks to ensure traceability and regulatory compliance in a GMP-compliant MDI manufacturing environment.
EDUCATION
Northeastern University
MS, Regulatory Affairs
SKILLS
ABOUT SIRISHA DANDU
As a Quality Assurance and Regulatory Affairs Specialist at Denison Pharmaceuticals, I leverage my MS in Regulatory Affairs from Northeastern University to ensure compliance with FDA regulations and standards. I have over 5 years of experience in this role, where I handle Electronic Document Management, Regulatory Submissions, Product Complaints, Annual Product Reviews, Quality Assurance Incidents systems (CAPA\'s, DEV\'s and INV\'s). I am also certified in FDA/NIH: regulatory Do\'s and Don\'ts, QMS Bootcamp, and Electronic Drug Registration and Listing (eDRLS). My goal is to contribute to the development and approval of safe and effective pharmaceutical products.
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