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+ View Contact
Keyskills: Draft ECN ECN ISO ECR Cfr FDA Dhf Dmr Food And Drug Administration
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