QA Validation Specialist

<p> </p><p></p><p>QA Validation Specialist reviews and approves documentation and oversees qualification and validation deliverables, associated with equipment, facility and utilities. </p><p>He/she reviews and approves validation documents and procedures associated with equipment, facility and utility operation, cleaning and maintenance. </p><p>He/she assures the deviations and changes are well documented and applicable corrective actions and systemic solutions are applied. </p><ul><li>Main responsibilities are: <ul><li>Overseeing validation and qualification deliverables: </li><li>Review and approve URSs; </li><li>Review and approve qualification and validation plans; </li><li>Review and approve validation documentation associated with equipment, facilities and utilities (DQ, IQ, OQ, PQ); </li><li>Review and approve the risk assessment related to equipment, facilities and utilities; </li><li>Review and approve the commissioning protocols and reports; </li><li>Review and approve FAT/SAT documentation; </li><li>Assure requirements traceability throughout the whole project validation file (from URS to PQ). </li></ul></li></ul><p></p><ul><li>Overseeing validation life cycle documentation: <ul><li>Review and approve equipment, facility and utility life cycle documents; </li><li>Ensure the correct application of the validation quality systems on the field and to define improvement plan; <ul><li>Understanding of cGMPs, GAMP, ICH Q7A and validation practices (IQ/OQ/PQ) and their application in practice. </li><li>Conducting periodic review of validated GxP equipment, facility and utilities. </li><li>Performing validation impact assessments prior to implementation of changes on equipment, facility or utilities. </li><li>Provide support in all quality-related issues, including GMP regulations, compliance with internal SOPs and all aspects of safe, reliable and consistent operation of the system. </li><li>Support the production &amp; technical services teams in the implementation of the validation activities. </li><li>Ensure the adequate management of validation deviations (be QA GMP Responsible) and potentials CAPA (be Compliance Authority). </li><li>Manage deviations and changes in order to ensure that these are well documented and that corrective actions are taken and followed-up upon. </li></ul></li></ul></li><li>Key Requirements:<ul><li>Bachelor’s degree in scientific or technical field (minimum)</li><li>3+ years of experience in validation activities in a pharmaceutical or biotech manufacturing environment (preferable)</li><li>Strong understanding of regulatory requirements and industry standards (FDA, EMA, ICH, etc.)</li><li>Strong communication and teamwork</li><li>Attention to detail and problem-solving abilities.</li></ul></li></ul><p></p><p></p><p></p>