Job Seekers, Please send resumes to resumes@hireitpeople.com
Job Details:
Must Have Skills (Top 3 technical skills only):
- Understand and adhere to the SOPs on Project Management, Change Management, Document Management and Computerized System Validation concept
- Preparation for compliance audit, attending meetings and assisting in addressing any issues
- GxP, 21 CFR Part 11, SDLC, GAMP knowledge and SOX knowledge
Nice to have skills (Top 2 only):
- Periodic review report and all related life cycle document updates
Detailed Job Description:
This request is to onboard new operation quality manager forISRM manager support for quality management program.This requires experienced resource with priorexperience in this skillset.
Minimum years of experience: 5+
Certifications Needed: No
Top 3 responsibilities you to shoulder and execute:
- Review of life cycle document for IT computerized systems, offline review and submission of comments where flaws are identified in the document
- Support in risk management activities, preparation for audits, assessments or inspections
- Train and coach the teams, as required, on relevant procedures, good documentation practice, good testing practice and CSV basics, where applicable
Interview Process (Is face to face required?): No.
