WE ARE HIRING!
Corporate CMO QA Specialist
Neuraxpharm is looking for people who want to make a difference and improve patients’ lives within the CNS area. We want individuals who will go the extra mile and make great things happen.
Being part of this team does not mean you are just working for a company, but for a cause!
Neuraxpharm is looking for a CMO QA Specialist based in Barcelona
(hybrid role)
Your Mission:
The CMO QA Specialist ensures that external CMOs consistently manufacture, test, and distribute products in compliance with GMP, GDP, ICH guidelines and Marketing Authorizations, maintaining and improving an effective QA system that protects product quality, efficacy, and patient safety. The role acts as the quality lifecycle expert for assigned molecules and FDFs, overseeing manufacturing and testing changes, resolving quality incidents, integrating new API sources, and assessing any modification impacting external manufacturing.
Your Major Accountabilities:
1. Write, review and approve technical documents: SOPs, master batch manufacturing records, analytical methods, material lists, specifications, stability studies, filed dossiers, Quality Agreements, environmental conditions, etc.
2. Write, review, approve and monitor CAPAs, deviations, OOS, complaints, change controls etc.
3. Write, execute or review qualifications (equipment, utilities, facilities, suppliers, providers, etc.) and validations (e.g. process, cleaning, transport, etc.).
4. Write, review and approve Product Quality Review reports.
5. Perform Compliance checks (internal procedures vs filed documentation).
6. Execute internal and external audits. Attend audits/inspections from Health Authorities and customers.
7. Prepare and execute GMP trainings.
8. Attend requests regarding quality related to marketed products.
9. Participate on the assigned projects
Your Specific Accountabilities:
10. Supervise the quality of the product and drive continuous improvement.
11. Support the assigned Product Lifecycle projects.
12. Supervise activities of the CMOs.
13. Supplier qualification management.
We would like you to have:
14. Bachelor’s or master’s degree in pharmacy, Chemistry or Biology degree.
15. 5 years’ experience in Quality Assurance Department
16. Strong knowledge of IT tools: Office, SAP and LIMS
17. Strong knowledge of GMP and Quality Management Systems: deviations/investigations, complaints and audits.
18. Excellent communication skills in English (written and verbal); additional languages are an asset.
19. Quality orientation, analytical thinking and stress management.
ABOUT US
Neuraxpharm is a leading European specialty pharmaceutical company focused on the treatment of the central nervous system (CNS), including both psychiatric and neurological disorders. It has a unique understanding of the CNS market built over 40 years.
Neuraxpharm is constantly innovating, with new products and solutions to address unmet patient needs and is expanding its portfolio through its pipeline and acquisitions.
The company has c. 1,000 employees and develops and commercializes CNS products through a direct presence in more than 20 countries in Europe, two in Latin America, one in the Middle East, one in Australia, and globally via partners in more than 50 countries. Neuraxpharm is backed by funds advised by Permira.
Neuraxpharm manufactures many of its pharmaceutical products at Neuraxpharm Pharmaceuticals (formerly Laboratories Lesvi) in Spain.
Be part of the team where you can count on us to deliver:
20. Individual Professional development in a leading European pharmaceutical company with an ambitious international growth strategy.
21. Attractive remuneration according to the experience and skills provided.
22. An inspiring leadership team that drives performance.
23. An inclusive culture promoting diversity across the teams that will inspire you every day with a passionate, a dynamic, a result focused and an expert&excellent team!
Interested in knowing more?
Have a look at what Neuraxpharm culture represents and what makes us a great place to work:
If you want to join us, this is your opportunity!
WE COUNT ON YOU, YOU COUNT ON US
At Neuraxpharm’s we ensure an inclusive, diverse, safe and respectful work environment for everyone in its organization. As we care for our people as much as we do for our patients, we are committed to guaranteeing a healthy, inclusive and equal opportunity workplace that enables employees to develop their professional potential, while ensuring their individual and collective satisfaction.
We are guided by a Diversity & Inclusion policy to ensure a business culture based on the principles of diversity, equality and inclusion. Our policy complies with European legal regulations and includes the necessary standards, processes and measures to be taken in the event of discrimination or harassment against any employee of the company.
We embrace and promote different cultures, gender identities, seniorities, ages and mindsets within the workplace, to bring different perspectives, styles and experiences to our business.