1d ago
QA Partners Specialist
QA Partners Specialist
Original Advert
We're building the future of medical dermatology by focusing on unmet patient needs and giving people the space to think independently, take ownership and make an impact that matters.
Our purpose is simple: to transform patients' lives by addressing real needs. We work with care, act with courage, keep things simple and focus our innovation where it makes a difference.
Recognised as a Top Employer in Spain since 2008 and in Germany since 2025, we continue to invest in an environment where people can grow and move forward.
If you care differently, you belong here.
Would you like to join our Quality Assurance team as a QA Partners Market Specialist?
If you're excited to be part of our Industrial Operations & QA team - working alongside top partners in the global pharmaceutical industry - this opportunity is for you!
We're looking for someone who brings strong experience, curiosity, and a genuine desire to keep learning and growing within our QA organization. If that sounds like you, you're in the right place!
Mission: The Quality Partners Specialist ensure that Almirall's partners are operating in compliance of GMP, GDP and specific local regulations, as applicable, according to the internal guidelines and whether the activities granted by the health authorities for the distribution of Almirall/Polichem products.
Functions:
Apply the Almirall Corporate Quality Policy related to the API, medicinal products, medical devices and cosmetics in relation to the distribution through partners.
Collaborate to establish and to apply corporate procedures for the management of the quality system associated with the distribution of products through Partners.
Participate in a cross-functional projects and quality initiatives within Almirall stakeholders.
To manage any quality related aspect required to the performance of the GMP/GDP activity and any regulation in force in any of the countries where the products are commercialized between the Partners and the Manufacturers.
To manage key GMP and GDP elements as deviations, OOS and change control, etc. between the Manufacturer and the Partner.
Execution GMP/GDP audit qualification plans to ensure the maintenance of partners' quality standards according to Almirall's procedures.
To ensure the Quality Agreement with the Partner and its compliance.
Maintain updated information regarding local regulations and coordinate them with manufacturers for their implementation.
To manage implementation of new GXP regulations related to its area of responsibility.
Apply the continuous improvement of quality in accordance with the ICH Q10.
Profile required:
Education: Bachelor's degree in Life science (Pharmacy, Chemistry, Biological sciences or similar subject).
Specific expertise:
1-3 years quality related experience in pharmaceutical or biopharmaceutical industry.
Knowledge of GMP/GDP and regulatory requirements (e.g., EU, FDA, ICH, MFDS, EAEU regulations...)
Technical working proficiency in quality systems.
Good knowledge and skills in the use of advanced personal computer programs and systems such as Trackwise and eDMS.
Ability to influence and collaborate with others.
Languages:
Advanced written and verbal communication skills in Spanish and English
Application managed by Almirall