QC Support Compliance Investigation Engineer (m/f/d)
Jobdescription
We are seeking a highly skilled and experienced QCSupport Investigation Expert to join our Quality Control team. Theideal candidate will have a strong engineering background andextensive experience in the pharmaceutical or biotech industry.
Theprimary responsibility of the QC Support Investigation Expert willbe to lead and support investigations related to quality controlissues, deviations, and non-conformances in our manufacturingprocesses.
KeyResponsibilities :
- Lead and conductinvestigations into quality control issues, deviations, andnon-conformances, ensuring thorough root cause analysis andeffective corrective and preventive actions(CAPAs).
- Collaborate with cross-functionalteams to identify and implement solutions to prevent recurrence ofquality control issues.
- Provide technicalexpertise and support for investigations, including data analysis,risk assessment, and documentation of investigationfindings.
- Develop and maintain investigationprotocols, reports, and documentation in compliance with regulatoryrequirements and company standards.
- Supportcontinuous improvement initiatives and contribute to thedevelopment of best practices for quality control investigationsand CAPA processes.
Functie-eisen
Qualifications :
- Bachelor'sor Master's degree in Engineering, Pharmaceutical Sciences, orrelated field.
- Minimum of 5 years of experiencein a quality control, quality assurance, or technical support rolewithin the pharmaceutical or biotechindustry.
- Strong knowledge of cGMP, FDA, EMA,and other regulatory requirements related to quality control andinvestigations.
- Proven experience in leadingand managing complex investigations, root cause analysis, and CAPAprocesses.
- Excellent analytical,problem-solving, and communicationskills.
- Ability to work effectively in across-functional team environment and drive collaborativeproblem-solving.
- Fluent in French andEnglish
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