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R&D Quality Manager
Novartis
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
- Manages technical complaints investigations to determine root causes and implement corrective actions to prevent recurrence.
- Collaborate with cross-functional teams to gather data, lead, and perform Root Cause Analysis to identify the likely root cause of events.
- Review and approve complaints as the site Investigation approver.
- Manage multiple investigations concurrently.
- Periodically analyze trends in technical complaints.
- Participate in audits and inspections, including inspection readiness activities.
- Handle data integrity escalations.
- Implement and drive global Data Integrity (DI) network initiatives
Essential Requirements:
- More than Over 10 years of practical experience in the chemical/ pharmaceutical industry or over 5 years of experience in pharmaceutical operations . In-depth knowledge of pharmaceutical facilities, manufacturing, and laboratory systems and processes-.
- Proficient in conducting Root Cause Investigations. Effectively collaborate with the Investigation team to ensure timely completion.
- Experienced in cGMP manufacturing, Quality, and Compliance.
- Action-oriented with strong skills in building relationships, problem-solving, planning and organizing, conflict management, coaching, and analytical thinking.
- Capable of completing routine tasks with minimal direction
- Fast learning abilities, able to manage investigations related to small molecule, biologic and CGT products as well as medical devices, packaging and distribution related topics
- Able to promptly communicate roadblocks and challenges, ensuring timely delivery of investigations.
- Excellent verbal and written communication skills.
- Project Management
- Sound knowledge of current international regulatory regulations, cGxP requirements and best practices, including EU-GMP guidelines
Employment Type: Full Time, Permanent
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18% candidates got the interview through other sources.
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What people at Novartis are saying
Quality Manager salary at Novartis
reported by
5
employees
with 11-19
years exp.
₹21
L/yr - ₹28.5
L/yr
103%
more
than the average Quality Manager Salary in India
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What Novartis employees are saying about work life
based on 1.5k employees
Flexible timing
Monday to Friday
No travel
Day Shift
Novartis Benefits
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Novartis Hyderabad / Secunderabad Office Location
Hyderabad Office
Novartis, Salarpuria-Sattva Knowledge City, Madhapur, Madhapur, Inorbit Mall Rd, Silpa Gram Craft Village, HITEC City
Hyderabad
Telangana 500081
Telangana 500081
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