Summary
About the Role
Major accountabilities:
- Makes quality decisions, addressing and resolving issues based on written procedures and analysis.
- Communicates batch record review status and issues effectively and promptly to quality and manufacturing.
- Performs batch record review on the manufacturing shop floor consistently.
- Ensures the conformance of the manufacturing and packaging processes to cGMP, policies and procedures.
- Direct support of fill finish production material.
- Review and approve manufacturing batch records logbooks and associated documentation and quality records such as deviations, investigations, DCEs, CAPAs and Change Controls.
- Partners with cross-functional teams to resolve documentation and batch related issues.
- Provides cGMP observations to management and escalates issues and challenges as needed.
- Provides critical quality expertise to quality and manufacturing supporting 24/7 operations.
- Other related duties as assigned.
Minimum Requirements:
- Bachelor’s degree required in Chemistry, Biochemistry or similar technical disciplines or related field with 5 years of experience in pharmaceutical-based GMP manufacturing operations including direct experience in documentation review.
- Previous experience with viral gene therapies and/or orphan disease indications is a plus.
- Knowledge of clinical trials and commercial manufacturing. This individual must have a strong knowledge and application of the CFRs and cGMPs.
- High level of accuracy and attention to detail.
- Good written and verbal communication skills with the ability to convey information clearly and accurately.
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EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers who are focused on building and advancing a culture of inclusion that values and celebrates individual differences, uniqueness, backgrounds and perspectives. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers and communities we serve.
Accessibility & Reasonable Accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
