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QA Specialist (H/F)


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. 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. 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. Minimum of 5 years’ experience in the pharmaceutical industry. Fluent in French and English. MS Office (Word, Excel, Outlook), Veeva Vault Fluent in French and English.

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