Summary
The Quality Assurance Specialist supports the maintenance at local level of the national quality management system as per GMP regulation and corporate guidelines as well as of all health regulated activities.
About the Role
For this role we offer a temporary contract.
Major Accountabilities
- Participate to the self-inspections as per approved annual plan and to the external audits (Health Authorities, Certified Bodies, Supplier,) or internal audits (QA global department of the company).
- Manage at local level the follow up of the CAPAs implementation.
- Assure the respect of the GMPs and Health Authorities requirements at local level and the compliance of the local quality system to the GMPs and corporate guidelines.
- Safeguarding of the quality of the medicinal products which have been manufactured by the radiopharmaceutical site.
- Supports on the APR achievement according to the calendar and assure the correct registration and archiving of the documentation at local level.
- Assure the execution of qualification, maintenance, calibration and revalidation programs at local level.
- Ensure the accomplishment of the ALCOA+ principles;
- Ensure that Out of specifications, Out of trends, deviations, CAPA, Change controls are addressed and recorded according to cGMP and SOPs.
- Participates, at local level, in the execution of the staff GMP training and the respect of the training annual plan.
- Assure the escalation to the Quality Site Head and to the Quality National Head in case of critical issues.
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Obligatory requirements:
- Education: Scientific Degree (Pharmacy, chemistry, Biology or similar).
- 2+ years of experience in a Quality Assurance department
- Strong affinity with and awareness of quality issues
- Good organizational skills including attention to details
- Solid knowledge of quality system (GMP). Basic knowledge of regulatory requirements is preferred.
- Fluent English and Spanish (Written and spoken).
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!
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 our 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
Benefits and Rewards: Read our handbook to learn about all the ways we'll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Division
Operations
Business Unit
Innovative Medicines
Location
Spain
Site
Murcia
Company / Legal Entity
ES51 (FCRS = ES051) AAA Mol. Ima. Iberica SLU
Functional Area
Quality
Job Type
Full time
Employment Type
Temporal (duración determinada)
Shift Work
No