393950BR
22. März 2024
Pays-Bas
About the Role
Location: Baarle-Nassau, Netherlands.
We are seeking a QA Systems and Compliance Expert (m/f/d) to help us maintaining and developing the quality system and compliance state of the Novartis Radioligand Therapies Site Baarle-Nassau (RLT Baarle-Nassau). He/she is responsible for the implementation of standards and procedures to ensure that the site complies with regulatory and GMP compliance requirements as described by authorities and by the Novartis quality manual. The role also ensures governance and quality oversight of external suppliers and the goods supplied to the site. The role is considered as a key support of the QA Systems Manager who is the operational manager of the role.
Key Responsibilities:
• Maintain the site’s quality system and ensures the QA system is compliant to regulatory and GMP compliance requirements.
• Support GAP assessments and implementation of global Novartis procedures into the site’s quality management system, as well as support the QA systems documentation and review process; defines updates and approve Quality systems documents and records.
• Represent RLT Baarle-Nassau in selected global projects and initiatives.
• Ensure quality systems related reports and records are approved on time: self-inspection planning, quality plan, training plans, etc. Also help in the definition of training requirements for the site and ensure that appropriate GMP training is given to the applicable site associates.
• Ensure that the site’s Quality KQI’s are monitored and reported. Support the drafting, and presentation of different quality oversight meetings and processes such as quality management review meeting or quality review board. But also perform the RLT Baarle-Nassau’s Annual Product Quality Reviews (PQR’s) on time and ensures that appropriate CAPA’s are defined and initiated.
• Support the preparation of Health Authority inspections and responses, not to forget to collaborate in the coordination of continuous improvement projects linked to RLT Baarle-Nassau Quality system.
• Responsible for ensuring quality oversight for materials purchased at or services provided by external partners (suppliers, contract manufacturers, service providers, etc.).
• Ensure that external suppliers are governed according Novartis procedures. Negotiate quality agreements, plan audits, follow-up on audit CAPA’s and ensures external quality risk assessments are in place. Responsible for the qualification of new suppliers.
We are seeking a QA Systems and Compliance Expert (m/f/d) to help us maintaining and developing the quality system and compliance state of the Novartis Radioligand Therapies Site Baarle-Nassau (RLT Baarle-Nassau). He/she is responsible for the implementation of standards and procedures to ensure that the site complies with regulatory and GMP compliance requirements as described by authorities and by the Novartis quality manual. The role also ensures governance and quality oversight of external suppliers and the goods supplied to the site. The role is considered as a key support of the QA Systems Manager who is the operational manager of the role.
Key Responsibilities:
• Maintain the site’s quality system and ensures the QA system is compliant to regulatory and GMP compliance requirements.
• Support GAP assessments and implementation of global Novartis procedures into the site’s quality management system, as well as support the QA systems documentation and review process; defines updates and approve Quality systems documents and records.
• Represent RLT Baarle-Nassau in selected global projects and initiatives.
• Ensure quality systems related reports and records are approved on time: self-inspection planning, quality plan, training plans, etc. Also help in the definition of training requirements for the site and ensure that appropriate GMP training is given to the applicable site associates.
• Ensure that the site’s Quality KQI’s are monitored and reported. Support the drafting, and presentation of different quality oversight meetings and processes such as quality management review meeting or quality review board. But also perform the RLT Baarle-Nassau’s Annual Product Quality Reviews (PQR’s) on time and ensures that appropriate CAPA’s are defined and initiated.
• Support the preparation of Health Authority inspections and responses, not to forget to collaborate in the coordination of continuous improvement projects linked to RLT Baarle-Nassau Quality system.
• Responsible for ensuring quality oversight for materials purchased at or services provided by external partners (suppliers, contract manufacturers, service providers, etc.).
• Ensure that external suppliers are governed according Novartis procedures. Negotiate quality agreements, plan audits, follow-up on audit CAPA’s and ensures external quality risk assessments are in place. Responsible for the qualification of new suppliers.
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
Essential Requirements:
• Bachelor’s or Master’s degree in a scientific area.
• Sound experience in a pharmaceutical or medical device QA/QC environment.
• Knowledge of cGMP.
• Dutch & English proficiency.
Desirable Requirements:
• Working experience in the pharmaceutical industry.
• Initial experience in Project Management.
• Experience with key GMP requirements such as EU GMP and FDA.
• Previous role in or interaction with radiopharmaceuticals or Molecular Imaging.
We offer permanent employment, with 2 months of probation period.
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
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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 hear more about Novartis and your career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• Bachelor’s or Master’s degree in a scientific area.
• Sound experience in a pharmaceutical or medical device QA/QC environment.
• Knowledge of cGMP.
• Dutch & English proficiency.
Desirable Requirements:
• Working experience in the pharmaceutical industry.
• Initial experience in Project Management.
• Experience with key GMP requirements such as EU GMP and FDA.
• Previous role in or interaction with radiopharmaceuticals or Molecular Imaging.
We offer permanent employment, with 2 months of probation period.
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
You’ll receive:
You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook. https://www.novartis.com/careers/benefits rewards
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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 hear more about Novartis and your 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
Operations
QUALITY
Pays-Bas
Baarle-Nassau
IDB Holland bv
Qualité
Full Time
Regular
No
