Process Validation - QA
VadodaraOn-siteMid Level
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The post's words + ASAI's dataOn-site in Vadodara.
OK with that?Mid Level level, usually 3-5 years.
You have them?No pay range in the post.
Not a repost. 4 of USV's last 35 posts were reposts; 3 of its 23 open roles are here.
6 Quality Assurance Engineer roles posted in Vadodara this week, 58 open. See them →
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The job post
293 words · from USV's careers site- Oversee the end-to-end execution and documentation of process validation, equipment qualification, and cleaning validation activities to ensure full regulatory compliance.
- Draft, review, and approve critical quality documents, including Validation Master Plans (VMP), protocols, reports, Risk Assessments, and Standard Operating Procedures (SOPs).
- Lead the investigation, root cause analysis (RCA), and impact assessment for market complaints received from customers and regulatory authorities.
- Manage and evaluate quality deviations, Out of Specifications (OOS), and Out of Trends (OOT) related to manufacturing processes and market products.
- Formulate, implement, and track Corrective and Preventive Actions (CAPA) arising from process failures, audit findings, and market complaints.
- Conduct periodic Product Quality Reviews (PQR/APQR) to evaluate process consistency, trending, and product quality over time.
- Coordinate cross-functionally with Production, R&D, QC, Regulatory Affairs, and Supply Chain to drive seamless validation runs and complaint resolutions.
- Act as the primary Quality Assurance point of contact for internal quality audits, client audits, and health authority inspections (e.g., USFDA, EMA).
- Define critical process parameters (CPPs) and critical quality attributes (CQAs) while implementing Quality by Design (QbD) principles across commercial products.
- Monitor statistical process control (SPC) data and trends to identify potential process variations before they impact finished product quality.
- Track and report key performance indicators (KPIs) and quality metrics related to process capabilities and complaint resolution timelines to senior leadership.
- Ensure strict adherence to global cGMP standards, ICH guidelines, and regional regulatory requirements for all commercial and validated products.
- Lead Risk Management initiatives (PFMEA) to identify, assess, and mitigate potential quality risks across drug product manufacturing processes.
- Oversee the Change Control management system to assess the quality impact of raw material, process, or equipment modifications on product validation status.
- Train and mentor junior QA staff on current validation practices, complaint handling procedures, and regulatory compliance standards.
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