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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