Srinivas Yedavalli, Ph.D

Operations Associate

Singapore, Singapore, Singapore31 yrs 9 mos experience
Highly Stable

Key Highlights

  • Over 20 years of experience in Quality functions.
  • Managed over 45 regulatory agency inspections.
  • Expertise in compliance remediation and quality assurance.
Stackforce AI infers this person is a seasoned Quality Assurance leader in the Biopharmaceutical industry.

Contact

Skills

Other Skills

21 CFR Part 11CAPACROChange ControlCleaning ValidationClinical DevelopmentCorrective and Preventive Action (CAPA)FDAGLPGMPGood Laboratory Practice (GLP)GxPHPLCLIMSPharmaceutical Industry

About

An accomplished business leader with over ~20 years of experience across a number of Quality functions in Operations, Manufacturing, Start up plants project Quality Lead, R&D Tech services, External Quality Manufacturing, and Supplier Audit & Compliance. A proactive individual with extensive hands on experience of the pharmaceutical business including small molecules & large molecules - API Drug Substances, Finished formulations, Sterile and Biologics manufacturing with reputed Biopharmaceutical companies (Pfizer, MSD Singapore, GSK & Dr.Reddys Laboratories Ltd). Managed more than 45 regulatory agency inspections with direct participation and helped in compliance remediation activities. Has worked globally across multiple regions and cultures. Experience with new start up facilities:: Commissioning & qualifications of Three (3) startup facilities as Project Quality Lead for C&Q activities (API & 2 new Formulation facilities). Core competencies: Data integrity, QMS, QRM (Quality Risk Management), Compliance Remediation, Audit & Compliance, Quality Systems, Deviation management, Commissioning & Qualifications (Facilities, Equipment & Automation systems), Auditing experience (Regulatory audits of FDA, MHRA, Japan and ANVISA etc, Supplier assessments, 3rd party contract manufacturers)

Experience

Novartis singapore

QA Operations

Jun 2025Present · 9 mos · Singapore, Singapore · On-site

  • QA Operations support, QC

Eli lilly and company

Data Quality Compliance Lead

Sep 2024May 2025 · 8 mos · Limerick, County Limerick, Ireland · On-site

  • New Biologics site Data Integrity Compliance with fully digital site

Gsk

Quality Audit & Compliance Operations Head - APAC

Aug 2020Sep 2024 · 4 yrs 1 mo · Singapore

Pfizer

External Supply & Business Development Quality Head, Asia Pacific

Jul 2019Aug 2020 · 1 yr 1 mo · Singapore, Singapore

Msd

3 roles

Associate Director, External Quality Assurance, Asia Pacific

Promoted

Aug 2015Jul 2019 · 3 yrs 11 mos

  • Responsible for External manufacturing Quality Assurance

Quality Assurance Lead

Promoted

Dec 2006Aug 2015 · 8 yrs 8 mos

Manufacturing Operations Specialist

Dec 2002Dec 2006 · 4 yrs

Dr. reddy's laboratories

Technical Operations R&D

May 1994Nov 2002 · 8 yrs 6 mos · India

Education

Technological University Dublin

Pharmaceutical Sciences & Computer System Validations (CQV) — Pharmaceutical Sciences

Jan 2015Jan 2019

Shobhit University

M.Sc — Organic Chemistry

Jan 2001Jan 2003

Indira Gandhi National Open University

MBA — Operations & Total Quality Management

Jan 1998Jan 2001

Andhra University

Bachelor of Science - B.Sc — Organic Chemistry

Jan 1989Jan 1991

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