Senior QA Specialist

Are you passionate about Quality Assurance and want your work to have a direct impact on global health?

We are looking for a Senior Quality Specialist (GMP) - Azuqueca de Henares (Guadalajara). We are not looking for someone who only reviews documents, but for a rigorous and proactive professional capable of ensuring maximum excellence in the manufacturing and release of biotechnological and essential treatments.

-Comply with GMP standards (at least the current version of EudraLex Volume 4 and 21 CFR 210, 211, and 820) for medicinal and combination products for human use.

-Prepare and review release specifications, shelf-life requirements, and customer requests.

-Review master batch records and their validation/compliance status in SAP (BOM/Routing).

-Manage deviations/non-conformities related to GMP at the site.

-Review and approve manufactured and packaged batches and related analytical data, including OOS when applicable, before market release.

-Review and sign certificates of analysis; perform periodic inventory checks; and manage deviation/non-conformity forms for packaging materials in accordance with EU and US standards and internal quality policy.

-Manage and support quality system activities, including complaints, CAPA, returns, PQR/APR, change control, validations, QTA, recalls, initial training, supplier qualification, and plant service compliance, according to internal procedures, GMP requirements, regulatory requirements, and customer expectations.

-Education: University degree in Pharmacy, Chemistry, Biology, or Health Sciences.

-Languages: Intermediate level of English and bilingual Spanish.

-Experience (years/area): Minimum of 3 years of experience in a similar role for a senior position.

-Specific Knowledge: Experience in Quality Assurance; extensive knowledge of GMP documentation review; knowledge of SAP/R3 and MS Office; knowledge of quality systems in production plants, including procedures, training, deviations/non-conformities, complaints, and audit support.

-Skills: Good communication skills, proactivity, ability to work under pressure, teamwork, problem-solving, good organizational skills, and persistence.

Contract: TEMPORARY - 6 initial months (with high possibility of becoming permanent staff).

Schedule: Full time with flexible hours for work-life balance.

Salary: Competitive salary based on experience.

Benefits: On-site canteen included.

Environment: International project with exposure to EU and US standards (FDA/EudraLex).