Process Validation Engineer Telangana

Immediate Openings on # Process Validation Engineer Pune Contract

Experience:3+ Years

Skill: Process Validation Engineer

Notice Period: Immediate

Employment Type: Contract

Work Mode: WFO/Hybrid

Job Description: Valuable in documentation ( E.g. GDP , in earlier exp if person is author of doc and worked in regulated industries like Medical device , Pharma Aero space etc) Experience with statistics Effective communication to have proper discussion (exp in handling manufacturing activities) Hands-on mentality to perform PV related activities (e g TMV, IQ, OQ PQ) Hands on shop floor is preferable Perform gap assessment and conduct remediation of documents with stakeholder inputs. Valuable understanding on the manufacturing specific QMS documents for Class-I, II and III medical devices. Supports the development and introduction of recent 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. Medical Device Experience with knowledge of FDA 510 K, ISPHONE_NUMBER, ISO 14971 standards preferred

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