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 conceptPreparation for compliance audit, attending meetings and assisting in addressing any issuesGxP, 21 CFR Part 11, SDLC, GAMP knowledge and SOX knowledgeNice to have skills (Top 2 only):Periodic review report and all related life cycle document updatesDetailed 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 documentSupport in risk management activities, preparation for audits, assessments or inspectionsTrain and coach the teams, as required, on relevant procedures, good documentation practice, good testing practice and CSV basics, where applicableInterview Process (Is face to face required?): No.