QA Specialist – QMS Support (Pharma | GMP | Compliance)
Location: Mumbai, India
Experience Level: Mid-level (2–5 years)
Work Mode: On-site
Job Type: Full-time | Regular
Job Summary
Novartis is hiring a QA Specialist – QMS Support to manage quality processes and ensure compliance with GxP and Novartis Quality Management Systems. The role involves supporting GMP documentation, regulatory inspections (PCA, NDA, periodic), change control, CAPA, and KPI reporting. Ideal for professionals with solid experience in pharmaceutical quality assurance, compliance, and risk management within a global framework.
Key Responsibilities
Support GMP compliance inspections for sites registered in Japan
Handle documentation and stakeholder coordination for PCA, NDA, and periodic inspections
Monitor, collect, and review critical GxP data and documentation
Support local Quality Systems and ensure SOP compliance
Prepare for and follow up on GMP inspections in collaboration with QA leadership
Support new product launches and product transfers
Manage local QMS processes: change control, escalation, CAPA, and risk management
Track KPIs and ensure timely quality reporting and trend analysis
Assist in internal audits, inspections, and compliance documentation
Ensure inspection readiness and procedural integrity of third-party and clinical trial material
Required Skills & Qualifications
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, or related field
2–5 years’ experience in pharmaceutical Quality Assurance or QMS
In-depth knowledge of GxP, GMP, quality systems, and compliance standards
Strong documentation review and regulatory understanding
Familiarity with Japan regulatory processes (PCA/NDA inspections) is a plus
Project management and decision-making skills
Effective communication and collaboration across teams
Fluent in English
Perks & Benefits
Competitive compensation package
Employee recognition and wellness programs
Comprehensive health coverage
Global learning and upskilling opportunities
Inclusion in Novartis’s global talent network
Access to Novartis Life Handbook for benefits and rewards
Company Description
Novartis, a global leader in pharmaceuticals, is committed to improving lives through innovative science and operational excellence. The company champions quality, compliance, and a strong culture of collaboration across global operations.
Work Mode
On-site – Based in Mumbai, India
Call to Action
Ready to make a difference in pharmaceutical quality assurance? Apply now to join Novartis and advance your career with one of the world’s most trusted and innovative healthcare companies.
Apply today on ThePharmaDaily.com to be part of a mission-driven organization.
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