353827BR
Sep 27, 2022
Netherlands

Job Description

40+ is the dedicated number of team members you would be joining at IDB (Advanced Accelerator Applications, Netherlands) whose mission is to bring new therapies to patients worldwide by producing radiopharmaceuticals for targeted radioligand therapy. IDB 's team embraces the culture of empowerment and teamwork.

The Product Steward
Maintains the oversight and knowledge for entire manufacturing process performed on site and throughout the entire commercial lifecycle, since transfer from development to date.

Your responsibilities:
• Monitor all critical variables and key variables as appropriate using statistical analysis and conducting regular product specific data trending
• Ensure that the Ongoing Verification Report (OPV) is established on time in alignment with the Annual Product Quality Review (APQR)
• Ensure data and trending are visible and communicated at shop floor level
• Lead / support root cause investigation of process failures, initiate and lead product improvement projects, involving cross-functional teams
• Create and maintain a product specific Quality Risk Analysis (QRAs)
• Ensure the continued state of validation (process, cleaning, ongoing verification etc.)
• Approve validation protocol and report related to technical changes.
• Provide the necessary data for the technical activities involved in transferring out a product, focusing on existing knowledge, through the appropriate documentation and supporting at the receiving site as needed
• Ensure inspection readiness for all process related aspects of assigned products

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Preferably MSc. in Pharmacy, Pharmaceutical Technology, Chemistry or equivalent
scientific degree.
• Fluent in English and proficient in site local language.
• Minimum 5 years of experience in process support, e.g., Validation Engineer or Process Expert role on the shop floor of pharmaceutical manufacturing and/or QA/QC
• Proven process understanding (Pharma, GMP, Regulatory aspects) is a must.
• Sound experience of data handling and applied statistics


Advanced Accelerator Applications, a Novartis company, is an innovative medicines company focused on the development of products for targeted radioligand therapy and precision radioligand imaging. We are committed to transforming patients’ lives by leading innovation in nuclear medicine.
AAA offers professionals the opportunity to face new challenges and pursue a career in a fast growing, technology driven healthcare company. We are passionate about improving patient health by leading innovation in nuclear medicine. We are looking for people who share our commitment to help us achieve this goal. Advanced Accelerator Applications is an Equal Opportunity Employer (EOE).
ONCOLOGY
ADVANCED ACCELERATOR APPLICATIONS
Netherlands
Baarle-Nassau
Technical Operations
Full Time
Regular
No
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353827BR

Product Steward

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