Validation Process Expert
7 days ago
Job Description
">Company Overview
L&T Technology Services Limited is a leading provider of digital technology and engineering services. Our company values innovation, collaboration, and customer satisfaction.
">Job Summary
">We are seeking a skilled Validation Process Expert to join our team. As a Validation Process Expert, you will be responsible for ensuring the quality and compliance of our manufacturing processes.
">Key Responsibilities:
">- Perform gap assessment and conduct remediation of documents with stakeholder inputs.
- Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
- Creation/modification of process flows within the Manufacturing/Service Departments.
- Development and maintenance Manufacturing/Service Work Instructions and related documents.
- Creation/modification of fixtures, tooling, equipment and systems to support operations.
- IQ, OQ, and PQ of fixtures, tooling, and equipment.
- Monitor and drive corrective action, CAPA and continuous improvement activities that directly impact performance measures by performing primary investigations, conducting data analysis, and implementing corrective actions.
- Support corrective and preventive actions in manufacturing using formal problem-solving tools and documentation.
Required Skills and Qualifications:
">- Medical Device Experience with knowledge of FDA 510 K, IS013485, ISO 14971 standards preferred.
- Must be able to work well as a member of a team with the ability to adapt quickly to changes and work efficiently in a fast-paced environment.
Benefits
">As a Validation Process Expert at L&T Technology Services Limited, you will enjoy a range of benefits, including:
">- A competitive salary package.
- Ongoing training and development opportunities.
- The chance to work with a talented team of professionals.
Others
">We are an equal opportunities employer and welcome applications from diverse candidates.
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