Experience

UPS Healthcare

• United States
• Transportation, Logistics, Supply Chain and Storage
• 400 - 500 Employee

• Healthcare Compliance QA Specialist

  • Aug 2022 - Present

  My main roles and responsibilities as a Healthcare Compliance QA Specialist are as follows:•Handling the Quality Management System through initiation and management of change controls, non conformances and performing detailed investigations for healthcare products.•Identifying and implementing effective CAPAs and performing Root Cause Analysis for NCs associated to healthcare products and ensuring their effectiveness by periodic monitoring.•Handling product recalls, returns and damages and maintaining control of saleable and non-saleable storage and releases.•Performing audits and ensuring compliance with regulatory requirements and sanitation requirements.•Performing reviews of SOPs, Certificates of destructions, reports and manuals and quality agreements. Show less

• Quality Assurance Specialist

  • Jun 2022 - Sep 2022



Lupin

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Assurance

  • Jan 2022 - Apr 2022

  Quality Assurance specialist with expertise on analytical data review and commercial batch release of mammalian and microbial biosimilars. Ensuring cGMP-GLP readiness and compliance of Quality Control labs for regulatory audits. Quality Assurance specialist with expertise on analytical data review and commercial batch release of mammalian and microbial biosimilars. Ensuring cGMP-GLP readiness and compliance of Quality Control labs for regulatory audits.



USV PRIVATE LIMITED

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive III

  • Apr 2020 - Dec 2021

  Quality Operations at USV Private Limited: Handling a multifaceted profile which primarily involves planning and execution of In-Vitro Bioassays (Percent relative potency estimation) along with a variety of Immunological assays (viz. ELISA, SDS-PAGE, Western Blot, Iso-electric focusing etc.) for a wide range of biosimilars manufactured for commercial market release, stability batches and in-process sample sourced from upstream and downstream processes. Handling and executing RealTime-PCR assays for quantifying Host Cell DNA (hcDNA) impurities in commercial release batches and also in multiple in-process stages of downstream manufacturing. Analytical method transfer and validation for quantitative and qualitative analytical methods. Handling and maintenance of primary and secondary cell lines and performing aseptic cell culture techniques along with characterization of cell lines. Audit compliance: Exposure to multiple audits by International and Domestic regulatory bodies in addition to various customer audits. Show less



Intas Pharmaceuticals

• India
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Executive

  • Jul 2017 - Apr 2020

  Quality Control of commercial batch release, stability batches and In-process stages for Biosimilars and Biopharmaceuticals. Analytical method transfer and validation for various analytical techniques along with immuno-bioassays. QMS and GLP management. Quality Control of commercial batch release, stability batches and In-process stages for Biosimilars and Biopharmaceuticals. Analytical method transfer and validation for various analytical techniques along with immuno-bioassays. QMS and GLP management.