Saidi U.

Quality Assurance & Regulatory Affairs working in Pharmaceutical & Biotech industries

United States of America
English

Quality Assurance and Regulatory affairs Professional over 16 years of experience in Pharmaceutical and Biotech industry., includes Non-sterile and sterile formulations in the form of solid dosage for...see more

  • Biotech, Pharma & Life Sciences
  • Quality
  • Operations
  • C-Level & Leadership

400

/hr
  • Pre-vetted expert
  • Confirmed hourly rate
  • Available on short notice

Experience

Associate Director Quality Assurance

Granules Pharmaceuticals, Inc.
3 years
Current position
Sep 2019 - Present
Oversee the site quality functions with respective to the compliance & operations. Granules India is a vertically integrated, high-growth pharmaceutical company with 34 years of proven ...see more

Sr. Manager Quality Compliance & Operations

Granules pharmaceuticals Inc.
4 years
Current position
Apr 2019 - Present
Overall site quality functions with respective to the compliance & operations, such as quality management systems, internal and external audits, vendor qualifications, SOP writing & tra...see more

Manager Quality Compliance & Operations

Granules pharmaceuticals Inc.
2 years
Mar 2017 - Apr 2019
Granules India is a vertically integrated, high-growth pharmaceutical company with 34 years of proven performance and increasing presence across the world.

Manager QA

InvaGen Pharmaceuticals Inc (A Subsidiary of Cipla Ltd.)
4 years
Feb 2013 - Mar 2017
Oversee the quality systems in terms of handling quality management systems (Change controls, deviations, Incidents, CAPA’s), internal audits and external audits as part of vendor quali...see more

Assistant Manager - Quality Assurance

Natco Pharma Limited - India
2 years
Jul 2011 - Jan 2013
• Handled Change controls, Deviations (incidents, Temporary changes), CAPA management system and trending of the quality attributes by statistical process controls (SPC) program. • Impl...see more

Sr Executive - QA

Aurobindo Pharma
3 years
Nov 2008 - Jun 2011
• Handled Change controls, PNC (Process Non Conformance), Exception reports and MNC (Material Non Conformance) and their CAPA management system. • Annual Product Quality Review (APQR’s)...see more

Sr. Executive - QA

Gland Pharma Limited
2 years
Aug 2006 - Oct 2008
• Handled Deviations, change controls, CAPA’s and market complaints. • SOP writing and implementation. • Conducted hold time studies for products, filters and equipment's. • Reviewed eq...see more

Executive - QA

Virchow BioTech PVT LTD.
2 years
Jul 2004 - Jun 2006
• Prepared BMR & BPR’s. • Handled Change controls, Deviations, CAPA’s. • Internal audits. • Involved technology transfer activities for different kinds of recombinant products. • Conduc...see more

Industries, roles and expertise

Industry experience

  • Biotech, Pharma & Life Sciences

Role experience

  • Quality
  • Operations
  • C-Level & Leadership