Quality Assurance Specialist

Quality Assurance Specialist Apply locations: ITA - Veneto - Verona Time type: Full time Posted on: Posted 3 Days Ago Job requisition id: R00265091 The QA Specialist, in collaboration with the QA Manager, is responsible for ensuring an adequate and efficient Quality Management System (QMS), in terms of documentation and processes, in compliance with the company's adopted compliance requirements. Qualifications/Skills: Degree in scientific disciplines (preferably in chemistry and pharmaceutical technologies, chemistry, pharmacy, biological sciences, or biotechnologies). At least 2 years of experience in a similar role within pharmaceutical companies. Good interpersonal, organizational (problem-solving), analytical skills, and attention to detail. Proficiency in common IT applications. Strong technical and regulatory knowledge (GMP, GDP, ISO 9001, ISO 13485). Good command of spoken and written English. Specific Responsibilities: The QA Specialist is expected to perform the following activities: Operate in compliance with company quality standards by applying relevant procedures within their areas of competence, respecting company quality policies and procedures. Verify the conformity of products and processes. Ensure the correctness and completeness of documentation for each batch record before distribution. Collaborate in the distribution and collection of batch record documentation from production departments. Review documentation related to production batches (both medicinal and non-medicinal), assessing compliance with batch specifications through collection and analysis of batch records and related documentation. Support the Qualified Person (QP) in batch release by providing a conformity judgment based on verification of documentation accuracy and completeness. Ensure adherence to batch release schedules, aligned with quality expectations and timelines. Assist in revising the master batch record as needed for updates. Review Audit Trails of computerized systems impacting GxP. Draft, update, and manage internal documentation (procedures, protocols, manuals, quality policies, reports), distribute approved copies, and maintain document archives, ensuring consistency with Good Manufacturing Practices and international standards. Manage quality complaints, non-conformities, and CAPA processes. J-18808-Ljbffr

Location: Verona, Veneto, IT

Posted Date: 7/7/2025