Spain
EuropeQuality Program Associate
2 мес. назад
SpainEuropeHybrid
Associate role focused on quality programs in a SaaS company transforming manufacturing operations in life science industries.
О компании
- Who we are is a software-as-a-service provider that transforms manufacturing operations in life science industries using advanced analytics and artificial intelligence. We are a fast-growing company entering an exciting new stage of expansion, and we are looking for ambitious new team members who are motivated to directly impact our growth and success. If you want your work to make a visible difference as we scale, this is the place to do it. is helping pharma manufacturers and CDMOs make better decisions in GMP operations. What makes us different from other manufacturing platforms? We help operations leaders and engineers avoid endless cycles of chasing data in disparate and heavy-handed systems and rapidly understand how to run their manufacturing processes bette
Обязанности
- Support the creation, maintenance, and execution of quality plans for customer implementation projects, ensuring alignment with GMP/GxP requirements.
- Assist in computer system validation (CSV/CSA) activities for solutions, helping draft and execute validation deliverables (validation plans, requirements and specifications, IQ/OQ/PQ test protocols, traceability matrices, and validation summary reports).
- Help coordinate GMP implementation projects: tracking deliverables, timelines, and action items across internal and customer teams.
- Provide support on validation and compliance consulting engagements, helping gather customer requirements and translate them into quality and validation documentation.
- Maintain documentation and records in line with data integrity (ALCOA+) and good documentation practices (GDP).
- Assist with change control, deviation, and CAPA documentation related to project delivery.
- Perform 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.
- Help prepare and organize validation and quality evidence to support customer audits and inspection readiness.
- Support and lead external audits performed by customers on the project documentation related to Execute and/or Platform implementation.
- Collaborate with product, engineering, and delivery teams to ensure quality is built into every solution delivery.
- Contribute to the continuous improvement of internal quality program templates, SOPs, and best practices.
Требования
- Bachelor's degree in a relevant field (Pharmacy, Biotechnology, Chemistry, Engineering, Life Sciences, Computer Science, or similar).
- 0–2 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.
- Familiarity with GMP/GxP concepts and quality systems, or a strong willingness and ability to learn them quickly.
- Solid written and verbal English (our working language), with the ability to produce clear, well-structured documentation.
- Strong attention to detail, organization, and documentation discipline.
- Comfortable working with software tools and digital systems.
- Willing to comply with and follow all regulations required when working in a highly regulated environment, such as ISO standards and GMP regulations.
Будет плюсом
- Exposure to Computer System Validation (CSV) / CSA and GAMP 5.
- Knowledge of data integrity principles (ALCOA+) and 21 CFR Part 11 / EU Annex 11.
- Experience with project management tools and methodologies.
- Understanding of pharmaceutical manufacturing operations (batch records, deviations, PQR, etc.).
- Spanish and/or additional languages.
- Familiarity with SaaS/cloud solutions or AI/analytics in regulated environments.
- Knowledge and experience with the Atlasian ecosystem
Другое
- Curious and eager to learn and excited to grow in an international, complex, regulated, and fast-moving domain.
- Detail-oriented and organized, you take accuracy and documentation seriously.
- Proactive and reliable, you follow through, take ownership, and flag risks early.
- A clear communicator and team player, comfortable working across technical and non-technical stakeholders, internally and with customers.
- Adaptable, you thrive in a scale-up pace and stay calm with a degree of ambiguity.
- Quality-minded, you understand that doing things right is not bureaucracy; it's how great medicines reach the people who need them.