QA CSV specialist
il y a 1 semaine
A key client of BioTalent based in Belgium are looking to onboard a QA CSV specialists for their growing quality assurance unit. This role will be responsible for overseeing all quality assurance activities related to verification (qualification) and validation of computerized systems within the facility. Key responsibilities include: Support projects as a Quality SME for the design, qualification, and validation of computerized systems. Ensure alignment related to priorities with Quality Validation Manager and maintain a strong collaboration with Bio Process Engineering, Validation, IT & Automation and CQV QA specialists. Provide guidance and process support to stakeholders in accordance with GMP regulations and procedures. Provide accurate and timely review and approval of validation documentation (e.g., URS (Technical Specifications), CQV protocols and reports, risk analyses). Responsible for appropriate management of defects / deviations, corrective and preventative actions, and change controls related to CSV scope. Monitor and support the implementation of continuous improvement and process changes, ensuring they are carried out in accordance with GMP and are appropriately assessed regarding any impact on validation. Participate in the maintenance of the QMS as part of the QA team Ensure escalation of significant/critical quality problems to the appropriate levels of management following the standards set by the QMS. Assist in hosting inspections or audits by regulatory authorities, Global Quality Auditing team, and others as needed. Identify opportunities for process improvements and lead initiatives to enhance quality and efficiency. Ensure a safe and healthy work environment. You will have: Minimum of 5 years' experience in the pharmaceutical industry. Demonstrated experience in Computerised System validation Fluent in French and English. IT knowledge : MS Office (Word, Excel, Outlook), Veeva Vault Ability to collaborate and influence across departments and levels. Fluent in French and English. On-site presence required. Reach out for more information.
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il y a 2 semaines
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