| Quality Systems Specialist (Hybrid) || Waltham, MA at Waltham, Massachusetts, USA |
| Email: [email protected] |
| From: Himanshu, DMS Visions INC [email protected] Reply to: [email protected] Hi, Hope you are doing well. Please find the job description given below and let me know your interest Title: Quality Systems Specialist (Hybrid) Location: Waltham, MA Duration: 5+ Months Job Description: Must Have Plus 2-3 years exp. In biotech or regulated industry (required) 2-3 years exp. Microsoft Suite (required) 2-3 years exp. Veeva or ComplianceWire admin (Highly desired) The Quality System Specialist, under the direction of the QS&C management team, will be responsible to support the global Quality Systems and their operations in ensuring compliance and fit for intended use in accordance with applicable global SOPs. Position details: Assist in governance of Quality System applications, including harmonization of processes across sites Assist in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEs Participate in additional user forums for gathering ongoing requirements and prioritization and triage issues Follow-up on requests, issues, and projects and report statuses to manager/ working teams Initiate and manage change controls, with associated documentation requirements, to completion Ensure system is maintained in a validated state by participating in periodic user access review, ongoing change management, business administration, and deviations/CAPAs associated with Quality Systems Support investigation, escalation, and resolution of issues identified on the system Support validation activities as requested; this includes but is not limited requirements gathering, validation planning, design qualification, authoring test plans and test scripts, execution of test scripts, discrepancy management, and authoring system description and validation summary reports Support manager with ongoing communication from vendor/IT where required Provide customer support through system and training management and onboarding of new users Generate metrics to support quality systems Support regular system updates/ releases and provide assessment of and recommendations regarding new features Maintain key user-related documentation and ensure it is kept up-to-date as new functionalities are enabled, created and/or modified ACADEMIC/TECHNICAL QUALIFICATIONS: Bachelors degree or higher in relevant computer/technical/quality/scientific discipline, preferably multi-disciplinary with a strong technical and quality background Minimum of 3-6 years of experience in a high volume commercial / clinical pharma / healthcare facility Proficient in MS Word, Excel, and Quality System processes. Experience with Veeva Vault Quality Docs, TrackWise, and ComplianceWire is a plus. Understanding and working knowledge of US FDA and European regulatory requirements and GAMP, andthe ability to determine phase appropriate requirements Knowledge of Regulatory Compliance and ICH Guidelines If you are interested, please share your updated resume and suggest the best number & time to connect with you. Thanks & Regards, Himanshu Gupta US IT RECRUITER, DMS VISIONS INC (972) 433-0229 Ext-104 | ( 470) 467-9946 | dmsvisions.com [email protected] LinkedIn: linkedin.com/in/himanshu-gupta-1888a1207 4645 Avon Lane, Suite 210, Frisco, TX 75033 Keywords: cprogramm information technology microsoft Massachusetts Texas Quality Systems Specialist (Hybrid) || Waltham, MA [email protected] |
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| Sat Oct 19 01:38:00 UTC 2024 |