Responsibilities
* Review and approve key GMP documentation generated by the Pharmaceutical Development area, including:
* Manufacturing, packaging, and labeling instructions for IMPs
* Analytical methods, specifications (LIMS), and specification dossiers
* ICH stability protocols and reports
* Method validation documentation
* Shelf-life justification reports for IMPs
* Master Manufacturing Plans
* SOPs related to equipment cleaning, operations, and room procedures
* Qualification protocols and reports for analytical equipment
* Manage and support core Quality activities:
* Deviations, CAPAs, change controls, and complaints
* Investigations of OOS, OOE, OOT, and related CAPA evaluation
* Quality Agreements (creation and maintenance)
* SOPs and controlled documentation for Quality & R&D
* Archiving and GxP documentation management
* Monitor IMP status across the clinical supply chain (manufacturing to end-of-trial)
* Support and participate in internal/external audits and regulatory inspections
* Manage submissions to AEMPS (manufacturing, import/export, controlled substances)
Requirements
* Bachelor’s or Master’s degree in Pharmacy, Chemistry, Biotechnology, or a related field
* 3–5 years of QA experience within an R&D or IMP-focused GMP environment
* Strong knowledge of ICH guidelines, GxP, and EU GMP Annex 13
* Experience collaborating with Manufacturing, Analytical, and Regulatory teams
* Fluent Spanish and professional English
* Detail-oriented, proactive, and strong problem-solving mindset
* Team player with the ability to work in cross-functional environments