04 ago
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Medium
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Barcelona
ph3The Position /h3 pReport to: Quality and Compliance Manager /p pThis is an early-career opportunity to join Aizon's Quality Validation function and support the delivery of our GxP software solutions into highly regulated pharmaceutical manufacturing environments. Working closely with senior quality, validation, and delivery colleagues, you will help build and maintain the quality program that underpins our customer implementation projects, from quality planning and computer system validation (CSV/CSA) to documentation and inspection readiness. The scope of this role is to ensure that projects derived from the implementation of Aizon’s products are properly implemented in GxP environments. /p pThe role is a key contributor to Aizon's success: by ensuring our projects meet GMP and regulatory expectations, you help our customers go live faster and with confidence, protecting data integrity and, ultimately, supporting the safe and timely delivery of medicines to patients. It is also a great launchpad to grow into more senior CSV, QA, or project delivery roles. /p h3Key Responsibilities /h3 ul liSupport the creation, maintenance, and execution of quality plans for customer implementation projects, ensuring alignment with GMP/GxP requirements. /li liAssist in computer system validation (CSV/CSA) activities for Aizon solutions, helping draft and execute validation deliverables (validation plans, requirements and specifications, IQ/OQ/PQ test protocols, traceability matrices, and validation summary reports). /li liHelp coordinate GMP implementation projects: tracking deliverables, timelines, and action items across internal and customer teams. /li liProvide support on validation and compliance consulting engagements, helping gather customer requirements and translate them into quality and validation documentation. /li liMaintain documentation and records in line with data integrity (ALCOA+) and good documentation practices (GDP). /li liAssist with change control, deviation, and CAPA documentation related to project delivery. /li liPerform internal audits to ensure that the project’s documentation related to the GxP implementation is properly developed and the project is executed according to the GAMP 5 guidelines. /li liHelp prepare and organize validation and quality evidence to support customer audits and inspection readiness.
/li liSupport and lead external audits performed by customers on the project documentation related to Aizon Execute and/or Aizon Platform implementation. /li liCollaborate with product, engineering, and delivery teams to ensure quality is built into every solution delivery. /li liContribute to the continuous improvement of internal quality program templates, SOPs, and best practices. /li /ul h3Qualifications: Must - Have /h3 ul liBachelor's degree in a relevant field (Pharmacy, Biotechnology, Chemistry, Engineering, Life Sciences, Computer Science, or similar). /li li0–2 years of experience (including internships) in quality, validation, regulatory affairs, or project support, ideally within pharma/biotech, a GMP setting, or a regulated software environment. /li liFamiliarity with GMP/GxP concepts and quality systems, or a strong willingness and ability to learn them quickly. /li liSolid written and verbal English (our working language), with the ability to produce clear, well-structured documentation. /li liStrong attention to detail, organization, and documentation discipline. /li liComfortable working with software tools and digital systems. /li liWilling to comply with and follow all regulations required when working in a highly regulated environment, such as ISO standards and GMP regulations. /li /ul h3Qualifications: Nice to Have /h3 ul liExposure to Computer System Validation (CSV) / CSA and GAMP 5. /li liKnowledge of data integrity principles (ALCOA+) and 21 CFR Part 11 / EU Annex 11. /li liExperience with project management tools and methodologies. /li liUnderstanding of pharmaceutical manufacturing operations (batch records, deviations, PQR, etc.). /li liSpanish and/or additional languages. /li liFamiliarity with SaaS/cloud solutions or AI/analytics in regulated environments.
/li liKnowledge and experience with the Atlasian ecosystem /li /ul h3The Human We’re Looking For /h3 ul liCurious and eager to learn and excited to grow in an international, complex, regulated, and fast-moving domain. /li liDetail-oriented and organized, you take accuracy and documentation seriously. /li liProactive and reliable, you follow through, take ownership, and flag risks early. /li liA clear communicator and team player, comfortable working across technical and non-technical stakeholders, internally and with customers. /li liAdaptable, you thrive in a scale-up pace and stay calm with a degree of ambiguity. /li liQuality-minded, you understand that doing things right is not bureaucracy; it''s how great medicines reach the people who need them. /li /ul h3What We Offer /h3 ul liUnique opportunity to join our company as it scales with excellent market traction and huge potential to grow globally /li liCompetitive salary (according to your experience/skills) /li liEquity, bonuses, and generous stock options /li liLanguage one-to-one training courses /li liCompetitive healthcare plans and benefits - Medical Dental Insurance /li liInternal training and certifications plan /li liFlexible Remuneration Options /li liCareer plan and scheduled salary reviews /li liTeam-building activities /li liTop-notch tech pack – We are Mac lovers /li liAn open and collaborative work environment with a young and dynamic team and a very international culture /li liAn opportunity for personal and professional growth, supported by stellar investors and the exciting challenges that come with joining a company at the start of its growth trajectory /li /ul pJoin our team and significantly impact our company's growth and success as we shake the pharmaceutical manufacturing industry. Apply now and be part of our journey to transform the way pharmaceutical companies operate. /p pWe are dedicated to maintaining an inclusive workplace in which all employees are treated with respect and are able to contribute meaningfully to society. Our organization brings together professionals from diverse backgrounds, representing more than 28 nationalities, and we take pride in being an equal-opportunity employer. /p pEmployment decisions are based exclusively on qualifications, merit, and business requirements. Applicants who require assistance or accommodation due to a disability may contact us at /p /p #J-18808-Ljbffr
📌 Quality Program Associate (Barcelona)
🏢 Medium
📍 Barcelona