392073BR
Apr 22, 2024
Netherlands
About the Role
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 Quality Control Officer contributes to the quality control processes of the medicinal products of Novartis RLT according to the Standard Operating Procedures, Work Instructions, Specifications and Methods of Analysis as laid down in the quality system.
The QC Officer has a deep knowledge of the analytical processes and systems in a strong GMP environment and acts as a Subject Matter Expert.
Your key responsibilities:
• The accurate execution of the quality control as defined in the specification of the respective medicinal
product, intermediate or raw materials;
• Awareness for any uncommon or unexpected incident, condition or detail during these controls and immediate notification of such deviation to the Qualified Person;
• Execution of the routine quality control testing conform analytical procedures and methods;
• Sampling, review and documentation of environmental monitoring according to the environmental control program effective on site. Reviewing the data and perform trend analysis;
• Manage and maintains the progress on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team;
• Collaboration with AS&T in project management, validation, revalidation and/or technology transfer related to analytical equipment;
• Coordinate and manage deviation and out-of-specification/out-of-expectation (OOX) investigations to be initiated, assessed, and closed out in timely manner;
• Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation;
• Communicate needs and opportunities for improvement of devices / software / methods conform GMP requirements and needs of customer.
The Quality Control Officer contributes to the quality control processes of the medicinal products of Novartis RLT according to the Standard Operating Procedures, Work Instructions, Specifications and Methods of Analysis as laid down in the quality system.
The QC Officer has a deep knowledge of the analytical processes and systems in a strong GMP environment and acts as a Subject Matter Expert.
Your key responsibilities:
• The accurate execution of the quality control as defined in the specification of the respective medicinal
product, intermediate or raw materials;
• Awareness for any uncommon or unexpected incident, condition or detail during these controls and immediate notification of such deviation to the Qualified Person;
• Execution of the routine quality control testing conform analytical procedures and methods;
• Sampling, review and documentation of environmental monitoring according to the environmental control program effective on site. Reviewing the data and perform trend analysis;
• Manage and maintains the progress on document generation, qualification execution, document review and approval. Escalate the issue/delay to management team;
• Collaboration with AS&T in project management, validation, revalidation and/or technology transfer related to analytical equipment;
• Coordinate and manage deviation and out-of-specification/out-of-expectation (OOX) investigations to be initiated, assessed, and closed out in timely manner;
• Responsible for all other activities related to qualification activities but not limited to change control, tag out, PM/Calibration program, equipment configuration, SOP generation;
• Communicate needs and opportunities for improvement of devices / software / methods conform GMP requirements and needs of customer.
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Minimum Requirements:
• Bachelor’s Degree in Scientific disciplines;
• Previous experience in the QC laboratory of a pharmaceutical company;
• Fluent in English. Good knowledge of Dutch as a plus.
• Analytical mindset and eye for detail.
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).
• Bachelor’s Degree in Scientific disciplines;
• Previous experience in the QC laboratory of a pharmaceutical company;
• Fluent in English. Good knowledge of Dutch as a plus.
• Analytical mindset and eye for detail.
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).
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
Operations
QUALITY
Netherlands
Baarle-Nassau
IDB Holland bv
Quality
Full Time
Regular
No
