Join to apply for the Qualification & Validation Specialist role at QbD Group Inscríbase ágil, consulte la descripción completa desplazándose hacia abajo para conocer todos los requisitos de este puesto. QbD Group team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD'er in Process validation. What do we expect from you as a Qualification and Validation Specialist? * Provide quality and validation oversight to ensure that validation, qualification and other life cycle activities are consistent with company validation policies, procedures and federal regulations; * Support process validations (IQ/OQ/PQ) and cleaning validation; * Identify critical areas for improvement and prioritize and execute the initiatives. * Perform or support nonconformance / CAPA root cause investigations,



defining action plans and driving these to completion; * Proceed according to the company's quality policy in all business activities; * Provide advice to improve the quality policies and validation procedures; * Provide coaching, training and guidance on validations; * Implement controls to ensure data integrity and traceability of Quality records; * Act as a subject matter expert during internal and external audits (e.g. FDA). Who are we looking for? * You have an academic background related to areas such as pharmacy, chemistry, biology, engineering and related fields. * You have at least 2 years of experience in qualifications/validations within validation departments in the pharmaceutical sector, medical devices, biotechnology... * You have experience in qualification/validation documentation management: VP, URS, IQ, OQ, PQ. * You have experience in complete processes of validations: protocols and validation reports. * You have an advanced level of English: you should be able to write technical documentation

📌 Qualification & Validation Specialist (Barcelona)
🏢 QbD Group
📍 Barcelona