QC Support Compliance Investigation Engineer
vor 23 Stunden
We are seeking a highly skilled and experienced QC Support Investigation Expert to join our Quality Control team. The ideal candidate will have a strong engineering background and extensive experience in the pharmaceutical or biotech industry. The primary responsibility of the QC Support Investigation Expert will be to lead and support investigations related to quality control issues, deviations, and non-conformances in our manufacturing processes.
Key Responsibilities:
- Lead and conduct investigations into quality control issues, deviations, and non-conformances, ensuring thorough root cause analysis and effective corrective and preventive actions (CAPAs).
- Collaborate with cross-functional teams to identify and implement solutions to prevent recurrence of quality control issues.
- Provide technical expertise and support for investigations, including data analysis, risk assessment, and documentation of investigation findings.
- Develop and maintain investigation protocols, reports, and documentation in compliance with regulatory requirements and company standards.
- Support continuous improvement initiatives and contribute to the development of best practices for quality control investigations and CAPA processes.
Functie-eisen
Qualifications:
- Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, or related field.
- Minimum of 5 years of experience in a quality control, quality assurance, or technical support role within the pharmaceutical or biotech industry.
- Strong knowledge of cGMP, FDA, EMA, and other regulatory requirements related to quality control and investigations.
- Proven experience in leading and managing complex investigations, root cause analysis, and CAPA processes.
- Excellent analytical, problem-solving, and communication skills.
- Ability to work effectively in a cross-functional team environment and drive collaborative problem-solving.
- Fluent in French and English
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