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| Job Location | Noida |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | Management Consulting / Strategy |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Description: We are looking for an experienced Quality Assurance Lead with strong background in Computer System Validation, management of Quality Management System and audits. You will be part of Corporate Quality Assurance Group. You will be the go-to person for process clarifications related to Organization Quality Management System and will be engaged in process definition initiatives, SDLC deliverables reviews, CAPA & Deviation Management, Defect Analysis, Internal Audits, Customer Audits and qualification activities.
Responsibilities: Define SOPs, Validation documents and quality metrics Conduct Internal Audits and manage customer audits Coach team members on Organizational Quality Management System Review SDLC deliverables to ensure compliance with QMS Lead Process Improvement Initiatives Oversee CAPA implementation Oversee Change Request Implementation Perform organization level analysis for defects, incidents, CAPA, deviation Participate in project planning meetings, retrospective meetings, risk management meetings and project closure meetings Conduct Process trainings
Requirements: Experience: 8 to 12 years Proficient in Computer System Validation, Software Qualification, Software Validation, Software Implementation and Compliance Proficient in formulating SOPs, Validation documents, assisting / supervising audits / inspections Proficient in management of Quality Management System (QMS) including updates & rollouts Good Understanding of 21 CFR part 11, GAMP, ISPE, ISO27001, GDPR Experience in CAPA management and Deviation Management Experience in SEPG activities like Defect analysis & baseline Experience in execution of Internal Audit for projects and departmental functions Skilled at working effectively with cross functional teams in a matrix organization Excellent Communication and Documentations skills Proficient in MS Word & Excel
,Keyskills :
quality management systemproject planningquality management21 cfrprocess improvement initiativesdefect analysisprocess improvementcustomer auditssoftware validationbusiness intelligencecorporate quality assurancerisk managementmanagement syste