Job Description QMO Consultant (Also referred as SQA)
Bachelor's degree or combination of relevant education and experience
Minimum 3 - 4 years of IT Quality Management experience
Preferably certifications such as ISO 9001, ISO 27001, Internal Quality Auditor, ITIL Certified etc
Knowledge of SDLC, QMS, ISMS & CSV, HIPAA, GDPR (Preferable).
Knowledge of Document Management System, Audit Management System, CAPA Management System, SVN or any Configuration Management System.
Good knowledge and experience in RCA, CAPA, Auditing processes
Experience on regulatory process for Life Science GxP Projects (Preferable)
Maintain Document Repositories related to QMS, ISMS and function under Configuration Management System / Document Management System.
Maintain Master List of Documents for QMS, ISMS.
Assist the Quality Head by completing the tasks as assigned on a need basis.
Follow-up with Project Teams to collect the data for QMS, ISMS related organizational data analysis e.g. Project Kick off, Project execution, project Closure, Best practices, Project metrics etc.
Be a part of Internal Quality Audit Team. Plan, schedule, execute, report, monitor and track the findings to closure.
Reviews the Document Repositories related to QMS, ISMS and suggest improvements.
Create, Review and approve function / QMS / project artefacts (As appropriate).
Participate in Project/ function meetings (As appropriate).
Ensure Quality Management System Trainings in-coordination with L&D team
Coordinate and facilitate the Project / support function team on QMS process implementations during project initiation, execution, closure.
Participate and maintain records related to Customer feedback, CAPA Management, Internal Quality Audits, Change Management, Risk, Issue Management, Configuration Management and other functional records.
Participate and contribute in organizational Computer System Validation activities (on need basis)
Status reporting to Stakeholders / Sr. Management on Quality System