Team Lead - Quality Operations
Job ID: REQ-10031264
Date Posted: Dec 02, 2024
Location: India
Job Summary:
We are looking for a dedicated professional to oversee quality operations, ensuring adherence to cGMP (Current Good Manufacturing Practices), regulatory standards, and company protocols. The role involves maintaining compliance with the Quality Assurance Agreement, Novartis Quality Manual, and Standard Operating Procedures to support seamless business operations.
Key Responsibilities:
- Supervise production and testing activities while ensuring strict compliance with cGxP, including data integrity and eCompliance.
- Assist in managing exception investigations.
- Review and approve documentation related to production, Quality Control (QC), and Analytical Science and Technology (AS&T) records.
- Conduct Master Batch Record (MBR) reviews.
- Support operational excellence and continuous improvement initiatives.
- Act as a Qualified Person, ensuring batch release compliance with registration requirements.
- Report technical complaints, adverse events, and special case scenarios within 24 hours of receipt.
- Manage the distribution of marketing samples (if applicable).
Performance Indicators:
- Ensure timely and GMP-compliant release of dosage forms.
- No regulatory inspection concerns in the area of responsibility that were not previously identified and communicated.
- Successfully contribute to continuous improvement projects.
- Ensure batch release is executed in full compliance with regulations.
Qualifications & Requirements:
Work Experience:
- Strong negotiation skills.
- Experience in project management and operations execution.
- Leadership abilities with a focus on cross-functional collaboration.
Key Skills:
- Expertise in GMP procedures, Quality Assurance (QA), and Quality Control (QC) testing.
- Effective people management and employee performance evaluation skills.
- Ability to work in ambiguous environments and drive continuous learning.
- Strong technological expertise and intelligence.
Languages:
- Proficiency in English.
Why Join Novartis?
Novartis is dedicated to transforming the lives of patients and their families through cutting-edge science and a collaborative work environment. Be part of a team that inspires and supports each other to drive meaningful change in healthcare.
Job Details:
- Division: Operations
- Business Unit: Innovative Medicines
- Work Location: Hyderabad (Office), India
- Company: Novartis Healthcare Private Limited
- Functional Area: Quality
- Job Type: Full-time
- Employment Type: Regular
- Shift Work: No
Accessibility & Accommodation:
Apply Now: From this link