Validation Process Lead
hace 2 semanas
About the Job
We are seeking a highly skilled and experienced Validation Process Lead to join our team. The successful candidate will be responsible for providing expertise and support to the Engineering Development Center (EDC) on all validation processes, including supporting hardware and software issues at the relabeling/Localization department and serving as the Global Labeling System Business Process Lead.
Your Key Responsibilities Will Include:
- Developing, implementing, and managing a validation program to current FDA and GMP requirements.
- Serving as Global Labeling System Business Process Lead.
- Providing timely hardware support to relabeling/Localization departments.
- Independently performing process, software, and/or equipment validation activities (IQ, OQ, PQ) and developing Master validation plans for new processes or updating existing Master validation plans if required.
- Reviewing and developing process/software and equipment validation protocols and reports.
- Supporting other functional areas during validation activities.
- Assisting EDC personnel in creating statistical sampling plans, inspection methodology, and quality procedures when required.
- Defining gauges, tools, and equipment for test methods developed.
- Working cross-functionally with other departments to accomplish tasks.
Requirements:
- Bachelor's or Licenciature degree in Chemical, Materials, Mechanical, Electromechanical, Electronic, Industrial, Biomedical, Electrical, or Industrial Maintenance.
- English Level desired: B2+ 80-90%.
- Experience: At least 3 years.
- Technical Competencies: ASQ certification (desired).
- Problem Solving.
- Studies in product validation and verification.
- Knowledge of statistical methods.
- Knowledge of QSR's.
- Execution oriented.
- Quality oriented.
- Communication.
- Innovation.
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