Novartis Hiring AS&T Expert – Quality Operations
AS&T Expert – Quality Operations
Job ID:
REQ-10013372
Date Posted:
July 1, 2024
Location:
Hyderabad, India
Job Summary
The Analytical Science and Technology (AS&T) Expert is responsible for the coordination and management of analytical activities related to commercialized products, providing scientific support to ensure the highest quality standards. This role involves collaboration across multiple functions, including quality control, production, registration, and marketing, ensuring compliance with regulatory requirements and continuous improvement of analytical methods.
About the Role
Location
Hyderabad, India
Position: AS&T Expert – Quality Operations
The AS&T Expert plays a crucial role in managing and coordinating the analytical activities for commercialized products. This includes overseeing method transfers, stability studies, and data compilation. The role requires significant experience in quality control, production, and regulatory compliance within a GMP environment.
Key Responsibilities
Coordination and Management
- Analytical Method Transfers: Coordinate and manage the transfer of analytical methods between laboratories.
- Stability Studies: Oversee stability studies, ensuring accurate data compilation and reporting.
- Quality Control Monographs: Compile monographs that describe test procedures and specifications for quality control.
- Scientific Analytical Support: Provide scientific support for quality control, production, registration, and marketing activities.
Data Presentation and Lifecycle Management
- Analytical Data Presentation: Present and discuss analytical data within local and international project teams.
- Lifecycle Management: Manage the lifecycle of analytical methods, ensuring compliance with pharmacopoeia and health authority standards, and defining necessary method improvements.
Deviation and Complaint Handling
- Deviation Management: Handle deviations, out-of-specification (OOS), out-of-expectation (OOE), and out-of-trend (OOT) cases, ensuring proper investigation and resolution.
- Cross-Functional Interface: Collaborate with Manufacturing Science & Technology, analytical development, production, and regulatory departments to address issues and implement improvements.
External Laboratory Coordination
- External Lab Management: Manage and coordinate analytical activities at external laboratories (Contract Research Organizations – CROs), supporting troubleshooting and continuous improvement initiatives.
- GMP Implementation: Implement Good Manufacturing Practice (GMP) requirements, ensuring compliance in all analytical activities.
Documentation and Budgeting
- Documentation Control: Compile and review analytical protocols, reports, and documents, including annual performance quality reports and registration documents in line with the Common Technical Document (CTD) format.
- Budgeting and Cost Control: Oversee budgeting and cost control for external analytical activities, ensuring efficient resource utilization.
Contribution to QC/AS&T Network
- Reference Substances Management: Manage reference substances and control samples to maintain quality standards.
- QC/AS&T Teams: Actively contribute to the Quality Control (QC) and Analytical Science & Technology (AS&T) network teams within the organization.
Essential Requirements
Experience
- Minimum 10 Years: At least 10 years of experience in the pharmaceutical industry or an analytical laboratory within a GMP environment.
Skills and Competencies
- MS Office and IT Applications: Proficiency in MS Office and other standard IT applications.
- External Orientation: Strong communication and collaboration skills, with a proactive approach to working with different organizational units.
- Innovation and Flexibility: Continuously strive for improvements, questioning processes and adapting to changes and challenges.
- Analytical Ability: Capability to analyze complex processes and identify opportunities for improvement.
Desirable Requirements
- Educational Background: Degree in Chemistry, Pharmacy, Biology, Engineering, or another related science.
- Language Proficiency: English proficiency is required, with German being optional.
Why Novartis?
At Novartis, our mission is to reimagine medicine to improve and extend people’s lives. We are committed to creating an environment that encourages innovation and collaboration among our associates. Join us to be part of a team that is dedicated to making a difference in patients’ lives.
For more information about our values and culture, visit our Strategy and Culture page.
Benefits and Rewards
Novartis offers a comprehensive benefits package designed to support both your personal and professional growth. Explore our Benefits and Rewards to learn more.
Join Our Novartis Network
If this role doesn’t align with your experience or career goals but you want to stay connected with Novartis for future opportunities, join our Talent Network to receive updates about suitable positions.
Additional Information
Division
Operations
Business Unit
Innovative Medicines
Employment Type
Full-Time, Regular
Shift Work
No
Accessibility and Accommodation
Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you need assistance during the recruitment process or to perform the essential functions of a position, please contact us at diversityandincl.india@novartis.com with your request and the job requisition number.
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