QA Specialist QMS Support
Job ID: REQ-10046745
April 10, 2025
Location: India
Summary
The QA Specialist in QMS Support is responsible for managing the quality aspects and projects within their area of responsibility, ensuring GxP conformity, and compliance with Novartis' Quality Management Systems.
Key Responsibilities:
GxP Compliance: Ensure and support overall GxP compliance within the region, collaborating with manufacturing sites and stakeholders.
Regulatory Support: Support regulatory compliance activities under GQP/QMS, including communication with stakeholders and the manufacturing sites regarding document-based GMP compliance inspections for Japan.
Inspection Support: Provide support for regulatory inspections, including Partial Change Application (PCA), NDA inspections, and periodic inspections for manufacturing sites.
Documentation Management: Efficiently collect and manage required information and documentation for inspections and health authority reporting.
Quality System Maintenance: Ensure that a local Quality System and SOPs are in place for GxP-related activities, maintaining compliance with cGMP through internal audits and training.
CAPA Tracking: Ensure timely completion and tracking of corrective and preventive actions (CAPA).
Project and Product Launch Support: Provide support for new product launches, product transfers, and GMP inspections.
Quality Performance Metrics: Ensure timely collection and reporting of quality KPIs for management.
Inspection Readiness: Assist in Health Authority inspections and internal audits by supplying relevant documentation.
Process Improvement: Contribute to the improvement and implementation of quality processes.
GxP Documentation: Prepare, review, and assist in the release of GxP documentation, including archiving and filing.
Essential Requirements:
Education: Degree in a relevant field (e.g., Quality Management, Life Sciences).
Experience: Experience in GxP and regulatory compliance, preferably in the pharmaceutical industry.
Skills:
Strong understanding of compliance requirements and quality management systems.
Knowledge of project management and risk management.
Experience in the handling of GxP documentation and inspections.
Familiarity with quality standards and continuous learning.
Languages: Proficiency in English.
Desirable Requirements:
Work Experience: Broader functional expertise in quality assurance.
Skills: Expertise in GxP, project management, and quality systems.
Why Novartis:
Novartis is committed to reimagining medicine to improve and extend people's lives. Join a global community of passionate individuals who collaborate to achieve breakthroughs that change patients' lives.
For more information on benefits and career opportunities, visit Novartis Careers.
Division: Operations
Business Unit: Universal Hierarchy Node
Location: Mumbai (Head Office)
Company: Novartis Healthcare Private Limited
Functional Area: Quality
Employment Type: Full time
Shift Work: No
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