Manufacturing and Quality Engineer
- Idexcel
- 5 - 8 years
- Chennai
- 2 months ago
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Job Description
Role & responsibilities
Position Name: Manufacturing Quality Engineer
Work Location: Chennai
Candidate exp in Yrs: 5-7 years
Job Description:
- Draft ECN, ECR for Engineering changes.
- Extensive knowledge, understanding on FDA CFR part 11, ISO13485, ISO14971 requirements.
- Draft and route QA stakeholder specific documents in one PLM tool.
- Complete Approval and review process in One PLM tool.
- Initiate an Audit an Enterprise change Notice (ECN)
- Review the changes requested for process changes, Equipment changes, line transfer, material change.
- Define requirements and other site-specific requirement for the change.
- Prepare and review draft QA documents (PFD, PFMEA, PCP, Validation documents, Process capability study reports, etc) anishd Co-ordinate with stakevholders for the evidence and regulatory/FDA requirements.
- Review process validation plans, protocols, and reports associated with Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
- Coordinate with internal stakeholders/SMEs to obtain approval and route it to respective stakeholders.
- Work with Sterility assessment, bio burden SMEs to close as per site requirement based on type of change
- Co-ordinate with Change analyst to close the ECN/ECRs after appropriate approval.
- Work on Gap assessment and remediation of DHF/DMR/ QMS documents.
- Hands on experience working with preparation, review and execution of Test methods, TMV, SOPs, Work instructions, and inspection procedures etc.
Job Classification
Industry: Recruitment / StaffingFunctional Area / Department: IT & Information SecurityRole Category: IT & Information Security - OtherRole: IT & Information Security - OtherEmployement Type: Full timeContact Details:
Company: IdexcelLocation(s): Chennai
Keyskills: Draft ECN ECN ISO ECR Cfr FDA Dhf Dmr Food And Drug Administration
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Idexcel Technologies Private Limited Idexcel is a Professional Services and Technology Solutions provider specializing in Cloud Services, Application Modernization, and Data Analytics. Idexcel is proud that for more than 21 years it has provided services that implement complex technologies that ...
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