Come join us and become a part of our world. Together we can discover new ways to improve and extend people's lives. As part of the global Novartis Group our sites in Kundl and Schaftenau are specialized in development and production of antibiotics and biologics.
Validation Lead Drug Substance (m/f)
Biologics Technical Development & Manufacturing, Quality Unit, Kundl
Area of Responsibility
- Responsible for developing, implementing and managing the Site process validation
- Revalidation strategies to meet cGMP requirements on time, on budget and quality to ensure that programs are compliant with inspection agencies' requirements and related SOPs
- Responsibility for all microbial processes (Up- & Downstream until bulk drug substance filling)
- Lead the process validation team operatively and functionally
- Establish, write, maintain Validation Master Plan for process validation & author complex validation protocols
- Maintain overview of state of validation at site, establish project prioritization across site & ensure conduct of site validation activities
- Proactively interact/consult with QA, Global MS&T and others on how to implement and align validation policies and standards
- Develop the strategy for continued process verification (CPV) and annual monitoring batches
- Ensure CPV plans are in place to monitor and trend critical process parameter, quality attributes etc.
- Actively participate respectively lead interdisciplinary and global work groups on process validation topics and related
- Maintain all activities in an inspection ready status and provide the necessary support in any audit
Education: University degree (MSc. or PhD) in Chemistry, Pharmacy, Biotechnology, Chemical Engineering, Pharmaceutical Technology or equivalent scientific degree
Languages: German and English fluent
Experience: At least 4 years of professional experience in manufacturing, technical development, or quality, minimum of 2 years of experience in executing process validation, having led and managed validation projects. Thorough understanding of manufacturing processes and strong working knowledge of applied statistics, quality systems and regulatory requirements across multiple health authorities. Proven project management experience in a cross-functional environment (e.g. multi-site, technical development, other functions). Expert in reviewing and writing technical reports.
Please apply online under the following link Online Application (Job ID 221085BR) Contact: Cornelia Walch, Senior Staffing Manager
We are offering a competitive salary in line with the market and based on your qualification, experience and individual competencies. Additionally we are offering an attractive Bonus/Incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The basic salary is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 52.048,50 per year).