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Sterility Quality Assurance Manager, Bon-Encontre, France

Full-time, On-site

*Must be a strong speaker of both English and French

Responsibilities:

• Define, document and implement of sterile best practices inside French sites

• Assure compliance of sterile practice with international regulation

• Support and oversight periodic media fill operations,

• Provide microbiological and sterilization expertise to quality, manufacturing, technical services, engineering throughout all phases of aseptic processes and for continuous improvement initiatives

• Train site personnel dealing with sterile products in best sterile practices

• Manage the monitoring of environmental control in cooperation with quality control and the production department, ensure trend reviews, define preventative and corrective action in case of need

• Provide technical and quality support in the investigation of deviations related to the control of microbiological and particulate contamination of classified areas

• Manage complex investigations related to related to sterile products and aseptic practices

• Participate in the definition, implementation and monitoring of corrective actions related to environmental deviations and aseptic practices detected (deviations, deviations from audits/inspections, etc.)

• Define according to regulatory requirements and to corporate requirement improvement plans related to sterile practices

• Provide expertise in the definition, and ensure their compliance, of practices related to the control of contamination/aseptic practices by reviewing cleaning procedures for classified areas, defining and implementing initial training plans /continuous staff empowerment and training

• Provide support to the quality control laboratory in the definition and qualification of methods related to microbiological and particulate control (review or definition of protocols, review of reports, proposals and management of improvement actions)

• Write, and review/approve assessments, procedures, technical reports, qualification documents related to aseptic practices consistent with corporate guidance, current industry practices and regulatory requirements

• Technical expert and responsible for implementing microbiology and sterilization validation programs for new and current products

• Support qualification of external lab dealing with micro analysis

• Participate in Curia expert council

• Support as SME, other sterile sites in Curia network in case of need