About the Role
Key Responsibilities:
Your responsibilities include, but are not limited to:
- Responsible for the daily operations and efficient utilization of resources to meet processing demands.
- Ensure the products are produced, inspected, stored and released in accordance with approved procedures.
- Support shop floor trouble shooting and problem solving as needed.
- Responsible for authoring, reviewing and/or approving GMP documents including but not limited to SOPs, Batch Records, Labels, Protocols, Reports, Validation documents.
- Ensure Good Documentation Practice are followed on the shop floor.
- Ensure production team receives complete cGMP training and are qualified to perform the required operations.
- Support compliance activities including deviations, CAPAs, Investigation and OOS and OOT
- Interview and hire production staff in conjunction with Production Support Leads and/or Head of Production.
- Implement cost control programs or procedures.
- Audit and review emergency paperwork and processes to ensure compliance.
- Monitor and regulate staffing needs to ensure optimum staffing levels are supporting business demands.
- Support a culture of safety, diversity and inclusion.
Shift: This role will be on a 4x10-hour shift schedule, Saturday - Tuesday. This position may involve mandatory overtime as needed.
Essential Requirements:
- Bachelor's degree in Engineering, Pharmacy, Pharmaceutical Technology, Chemistry preferred.
- 4+ years’ experience in Aseptic/GMP manufacturing process support role in the pharmaceutical industry, experience with radiopharmaceuticals is preferred.
- Good understanding or capacity to quickly understand production processes, scientific & technical (automation) understanding.
- Change management, adaptability, ability to work under pressure.
- Excellent organizational and time-management abilities.
Role Requirements
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
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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