Job Title: Specialist – Quality Operations
Job ID: REQ-10015156
Date Posted: Sep 03, 2024
Location: Hyderabad, India (Alternative: Telangana, India)
Division: Operations
Business Unit: Universal Hierarchy Node
Company / Legal Entity: IN10 Novartis Healthcare Private Limited
Functional Area: Quality
Job Type: Full-time (Regular)
Shift Work: No
Summary
Manage quality aspects and projects within the assigned area of responsibility. Ensure GxP conformity and compliance with Novartis Quality Management Systems (QMS). Provide oversight of production/testing activities, support investigations, batch release, and continuous improvement projects.
Key Responsibilities
Oversee all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance.
Support exception investigations and provide guidance on resolutions.
Review and approve production, QC, and Analytical Sciences & Technology (AS&T) records.
Conduct Master Batch Record (MBR) reviews.
Support Operational Excellence (OpEx) improvement projects.
Act as Qualified Person (QP) for batch release in compliance with product registration.
Report technical complaints, adverse events, or special cases related to Novartis products within 24 hours of receipt.
Manage the distribution of marketing samples (if applicable).
Key Performance Indicators (KPIs)
On-time and GMP-compliant release of dosage forms.
No unexpected inspection findings within area of responsibility.
Successful support of continuous improvement projects.
Accurate and compliant batch release execution.
Minimum Requirements
Work Experience
Background in QC/QA in the pharmaceutical/biotech industry.
Experience with environmental monitoring and cleanliness zones.
Proven ability in collaborating across functional boundaries.
Skills
Strong knowledge of Quality Management Systems (QMS).
Expertise in BMR/BPR review.
Proficiency in batch release processes.
Ability to conduct regulatory compliance checks.
Languages
English (required).
Why Novartis
Helping people with disease and their families takes more than innovative science. It takes a community of passionate people working together to achieve breakthroughs that change patients’ lives. Be part of this mission and help create a brighter future.
🌍 Learn more: Novartis People & Culture
📖 Benefits: Novartis Life Handbook
🔗 Join the Talent Network: Sign up here
Accessibility & Accommodation
Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the recruitment process or in performing job functions, please email diversityandincl.india@novartis.com with the job requisition number and your request.
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