Summary
Responsible for managing quality aspects within area of responsibility and to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements and the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures
About The Role
Position Title: Expert, QA Ops - Lifecycle Management
About The Role
This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objectives.
Key Responsibilities
Your Responsibilities Include, But Are Not Limited To
- Operational
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and
- eCompliance
- Support exception investigations (complex/critical)
- Support change control activities relating to complex changes
- Support OpEx improvement projects
- Execute batch release in compliance with registration according to local requirements as technical responsible person
- HSE
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Participate in HSE risk assessments
- Preparation and participation to internal HSE audits
- Responsible for participating in initial training and retraining
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
- University degree with a scientific / technological background (e.g., Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- 8-10 Years of relevant experience in pharmaceutical manufacturing in providing operational QA oversight, supporting audits or new product launches/tech transfer
- Several years of experience in pharmaceutical quality control, quality assurance or production
- GMP experience will be an added advantage
- Strong organizational and time management skills
- Quality oriented with attention to details
- Highly proactive, self-motivated, professional and dedicated
Why consider Novartis
236 million lives were touched by Novartis medicines in 2022, and while we're proud of this, we know there is so much more we could do to help improve and
extend people's lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse,
equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we
collaborate with courage to aggressively and ambitiously tackle the world's toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do at Novartis!
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients lives. Ready to create a brighter future together https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
