Onesource is Hiring: Drug Substance Quality Assurance (DS – IPQA) Specialist in Bengaluru

Location: 📍 Doddaballapur, Bengaluru
Industry: 🧪 Biologics | 🧬 Drug Substance Manufacturing
Job Title: Drug Substance Quality Assurance (DS – IPQA) Specialist

🚀 Exciting Opportunity with Onesource!

Are you a Quality Assurance professional with a passion for biologics and drug substance manufacturing? Onesource is hiring a Drug Substance Quality Assurance (DS – IPQA) Specialist at its Doddaballapur facility in Bengaluru.

This is your chance to join a leading team that plays a critical role in ensuring product quality and regulatory compliance in the fast-growing biopharmaceutical industry.

🧬 About the Role

As a DS – IPQA Specialist, your primary responsibility is to ensure that drug substance manufacturing activities comply with current Good Manufacturing Practices (cGMP) and international quality standards. You will collaborate closely with teams across Manufacturing, Quality Control, and Regulatory Affairs to uphold the highest standards of quality.

✅ Key Responsibilities

Provide shop-floor QA oversight for drug substance production.
Support batch release activities with thorough documentation reviews.
Review and approve batch manufacturing records, deviations, change controls, and CAPAs.
Conduct GMP documentation reviews, risk assessments, and quality impact evaluations.
Assist in internal audits, regulatory inspections, and client audits.
Lead and support deviation investigations and product quality complaint resolution.
Ensure compliance with global regulatory standards like FDA, EMA, and ICH guidelines.

🎓 Qualifications

A Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related field.
3 to 15 years of Quality Assurance experience in a GMP-regulated drug substance manufacturing environment.
Deep understanding of upstream/downstream processing, in-process controls, and quality systems.