Résumé
About the Role
Major accountabilities:
- The Quality Operations Specialist is responsible for first level, hands on, day-to-day cGMP facilitator role for all site related GMP activities even shifts. Quality Operations Specialist with site staff, who are performing the daily operational functions in support of their effort to produce quality products. This role ensures that the quality strategy is implemented and that there is a continuous drive to improve product and process quality within the PU, QC labs, and other support areas.
Key performance indicators:
- Shopfloor Activities: Conduct routine Quality Operations related activities at shopfloor including, but not limited to, observations and walkthroughs
- Perform training of events on shopfloor for PU and QC laboratories as well as other support areas, ensuring that deviations records are initiated adequately in deviation management system
- Review Activities: Review and approve production electronic batch records (EBRs), and/or QC related documentation, to ensure adherence to Novartis policies, SOPs, and cGMP requirements
- Interface closely with PU and QC to assist with batch record/QC data review, release, and compliance issue resolution
- Actively participate in process improvement initiatives aiming for Right First Time (RFT) on documentation and deviation reduction
- Ensures levels of documentation are adequate and compliant to existing procedures
- Write, review and approve Standard Operating Procedures (SOPs), Work Procedures (WPs), and Forms (FRMs), as needed
Essential Requirements:
- Min. 2 years of experience in pharmaceuticals is preferred
- Knowledge and understanding of cGMPs, keeping up to date with current industry issues and changing regulations
- Excellent oral and written communication skills are required
- Demonstrate leadership ability and excellent interpersonal skills
- Ability to work as part of a team
- Strives for simplicity and clarity
- SAP, 1QEM, MES, LIMS knowledge is preferred
- English
Why Novartis?
Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards:
Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: Novartis Life Handbook
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
