Katalyst Healthcares and Life Sciences
Responsibilities:
- d ownership for material identification, material segregation, classification of defect types including the successful application of thAccountability anese techniques on a day-to-day basis in manufacturing.
- Analyse/review effectiveness of preventive and corrective actions. Review root cause investigation according to an established process.
- It is also understood that an associate may receive special projects outside of this list.
- EUMDR Class II & III Compliance Projects
- Works in a cross-functional team to assess Supplier Validations and general documentation for compliance to EUMDR requirements and perform required remediation activities.
- Works with supplier base to identify gaps to EUMDR requirements, specifically related to Process Validation.
- Support quality improvement initiatives such as process and product characterizations
- that lead to continuous / cost improvements.
- Conduct benchmarking to develop more effective methods for improving quality.
- Approve IQ, OQ, PQ, TMV or Software Validations.
- Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk.
- Collect data and execute/conduct various analytical/statistical analysis and interpretation as part of process improvements and day-to-day support.
- Conduct investigation, bounding, documentation, review, and approval of nonconformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
- Minimum required education and experience: Bachelor's degree or equivalent with 8+ years of experience, Master s degree with 5+ years of experience, Doctoral degree with 3+ years of experience
- This position will require relevant experience working in manufacturing/operations.
- In-depth knowledge of product/process Risk Management (FDA and ISO standards) is required.
- Experience with a proven track record of implementing appropriate risk mitigation.
- Good technical understanding of manufacturing equipment and processes is required.
- Advanced knowledge and experience in the areas listed in the Duties and Responsibilities associated with the position.