Junior Qualification and Validation Specialist - Barcelona
QbD Group · Rubí, Catalonia, ES
QbD Group team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies...
Job description
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?: As a Qualification & Validation specialist,you work on multiple projects in Barcelona within several organizations within the pharmaceutical or Medical device related industry . You are responsible for effective and efficient validation and qualification of laboratory equipment, cleanrooms, utilities, HVAC systems, GMP production equipment, medical devices and processes. Main Responsabilities: - 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 t...