? We are looking for a QA Specialist (QC Laboratory) to join our Quality Assurance Team. ?Main Responsibilities: As QA Specialist (QC Laboratory), your responsibilities will include: * Act as the Quality Assurance representative within the Quality Control laboratory, ensuring compliance with GMP regulations and quality standards. * Provide active QA on-the-floor support, ensuring immediate quality guidance and promoting GMP and documentation best practices across laboratory activities. * Perform critical review of analytical documentation, laboratory records, calculations, chromatograms, integrations, analytical results and raw data. * Ensure Data Integrity compliance following ALCOA+/ALCOA++ principles, guaranteeing traceability, reliability, availability and integrity of both electronic and paper-based records. * Oversee GMP-compliant use of laboratory computerized systems and equipment, including LIMS, Empower 3, Gen 5 and other analytical platforms. * Review user access management, audit trails, backups and data archival processes whenever applicable.



* Participate in deviation investigations, root cause analysis, impact assessments and CAPA definition, implementation and effectiveness verification. * Prepare, review and improve SOPs related to Quality Control, Data Integrity, raw data management, computerized systems and audit trail reviews. * Support the qualification and training of laboratory personnel in GMP requirements, Data Integrity principles and Good Documentation Practices. * Support analytical method validation and transfer activities, ensuring compliance with applicable regulatory requirements. * Collaborate closely with QC, QA, IT, Validation and other cross-functional departments to maintain a culture of quality and continuous improvement. ?Assessment Criteria: * Bachelor’s degree in Chemistry, Biotechnology, Biology, Biochemistry, Pharmacy or other related scientific discipline. * Minimum 4 years of experience in QA, QC or equivalent roles withi

📌 QA Specialist (Elorz)
🏢 3PBIOVIAN
📍 Elorz