Резюме
Location: Halle (Saale), Germany
As a Process Expert you will provide front line support to manufacturing, working with the production teams to ensure each batch is manufactured safely and in compliance with the batch instructions and quality requirements. You will act as our Subject Matter Expert (SME) for product and process knowledge and will be the first point of contact for product and process related issues. Drives investigations to true root cause, and implementation of corrective and preventive actions.
About the Role
Key Responsibilities:
- Manage and maintain manufacturing documentation including Master Batch Record, applicable SOPs, risk assessments, protocols, and other documentation as needed.
- Technical writing/Reviewing to support manufacturing operations including but not limited to, Standard Operating Procedures (SOP), batch records and white papers.
- Collect data for ongoing process verification (OPV), support tracking and evaluation of product performance and implementation of CAPAs.
- Authoring/Owning investigations related to material transfer, API synthesis, Drug Substance formulation, Drug product filling, inspection, and packaging.
- Ensure processes are always inspection ready.
- Support process optimization and new technology introduction for continued productivity improvement, as appropriate.
- Review validation protocols and reports. Support the execution of process validations, and short-term improvement projects.
- Provide guidance and support to production team through training and knowledge sharing.
- Will demonstrate leadership capabilities and guide processes to closure/completion, while following all required guidelines and procedures.
Essential Requirements:
- Bachelor’s degree in engineering, Pharmacy, Pharmaceutical Technology, Chemistry or relevant experience in lieu of degree.
- 3 years’ experience in a process support shop floor role in GMP manufacturing and/or QA/QC.
- Proven process understanding (Pharma, GMP, Regulatory aspects).
- Strong awareness of quality issues. Compliance investigations experience required.
- Excellent technical writing skills
- Fluent in German and English
Desirable Requirements:
- Previous Radio pharma experience a plus
- Prior leadership and/or high cross-functional experience preferred
Commitment to Diversity and Inclusion:
Novartis is committed to diversity, equity, and inclusion. We strive to build diverse teams that are representative of the patients and communities we serve. We are dedicated to creating an inclusive workplace that fosters bold innovation through collaboration and empowers our employees to reach their full potential.
Our hiring decisions are based on equal opportunity and the best qualifications, regardless of gender, religion, age, skin color, race, sexual orientation, nationality, or disability.
Support for Applicants with Disabilities:
Join our Novartis Network:
If this position does not match your experience or career goals, but you would still like to stay connected with us and learn more about Novartis and our career opportunities, please 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
Benefits and Rewards: Learn about all the ways we’ll help you thrive personally and professionally.
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