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TruPharmaRX
Quality Manager
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Job Description
Overview We are seeking a highly motivated and detail-oriented Sterile Quality Manager to lead our sterile manufacturing quality assurance efforts. In this pivotal role, you will oversee all aspects of quality control and compliance within our sterile production environment, ensuring that products meet the highest standards of safety, efficacy, and regulatory adherence. Your leadership will drive continuous improvement initiatives, uphold rigorous quality systems, and foster a culture of excellence across cross-functional teams. Join us to make a meaningful impact on healthcare quality and patient safety through your expertise in sterile manufacturing processes. Duties Lead the development, implementation, and maintenance of comprehensive quality management systems aligned with industry standards Conduct regular quality audits and inspections to verify adherence to regulatory and legal compliance standards in sterile production environments. Oversee sterilization processes, ensuring compliance with USP Manage non-conformance investigations, root cause analysis, and corrective/preventive action plans to address quality issues promptly and effectively. Facilitate training programs on quality standards such as USP Lead cross-functional communication efforts to ensure alignment on regulatory requirements, quality objectives, and process improvements across departments. Experience Proven experience practicing in an industrial or manufacturing engineering role within sterile or pharmaceutical production environments. Extensive knowledge of USP and ISO classifications Demonstrated expertise in conducting quality audits, managing QA/QC processes, and implementing quality assurance systems in a regulated setting. Strong background in manufacturing processes with a focus on sterile environments, including sterilization techniques and validation protocols. Effective team leadership capabilities with experience managing multidisciplinary teams and fostering a culture of continuous improvement. Excellent communication skills for engaging with regulatory bodies, internal stakeholders, and external auditors to ensure ongoing compliance and quality excellence. Join us to lead our sterile manufacturing quality initiatives with passion and precision—helping deliver safe, reliable products that improve lives worldwide!