DirecciónAbout the role
Location : España, Zaragoza
We are seeking a Microbiological Supervisor to support the QC Manager to ensure that Quality Control processes for materials acceptance, batches quality control, and QC equipment validation / qualification are implemented and fully compliant to cGMPs regulation, corporate and national guidelines.
This role will work directly with the Microbiologic Quality team and reports to the Microbiological Responsible.
Key Responsibilities :
- Acceptance of raw materials, packaging materials,and semi-finished products according to specifications.
- Ensure that all QC processes, equipment and software are validated / calibrated according to the Validation Master Plan.
- Ensure that all methods used in QC analysis are validated according to SOPs and cGMPs; but also support the adequacy of the SOPs of QC Department.
- Perform the APR achievement according to the calendar.
- Support the audit trail review of the quality control equipment software; as well as the verification of the data integrity of the QC software.
- Maintain, review and approve the records of the QC activities.
- Ensure that all QC materials are properly and safely stored, identified, labelled recorded, and monitored according to SOPs and specifications;
to ensure that the stock of materials and reagents are available and ordered.
- Ensure that out of specifications, out of trend, deviations, CAPA, change controls related to the QC Department are addressed and recorded according to cGMP and SOPs.
- Collaborate with QC Manager for the periodical self-inspections and external audits (Health Authorities, Certified Bodies, Supplier).
Commitment to Diversity & Inclusion :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
- Scientific Degree such us Microbiology, Biotechnology, Pharmacy, Chemistry or equivalent.
- Spanish & English proficiency.
- Experience in a Quality Control Department.
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
We offer a market-competitive base salary in line with your qualification, experience and individual proficiencies, learning & development options, and worldwide career opportunities within a growing multinational pharma company that develops a job with direct impact on cancer patients .
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 Advanced Accelerator Applications?
Thousands of people die of cancer around the world every day. At Advanced Accelerator Applications, a Novartis company, our mission is to transform lives through radioligand therapy in nuclear medicine to fight several leading types of cancer.
How will we continue to be on the cutting edge of medicine?
We believe new groundbreaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges.
Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
This employer is a corporate member of myGwork - LGBTQ+ professionals, the business community for LGBTQ+ professionals, students, inclusive employers & anyone who believes in workplace equality.
