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Quality Systems Specialist

1 month ago

Waltham, Massachusetts, United States Planet Pharma Full time

Join Planet Pharma as a Quality Systems Specialist and contribute to ensuring compliance and fit for intended use in accordance with applicable global SOPs.

Key Responsibilities:

Assist in governance of Quality System applications, including harmonization of processes across sites

Participate in gathering requirements for improvements and ongoing maintenance by participating in meeting/workshops with Site Process Owners and business SMEs

Follow-up on requests, issues, and projects and report statuses to manager/ working teams

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

Requirements:

Bachelor's 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, and the ability to determine phase appropriate requirements

Knowledge of Regulatory Compliance and ICH Guidelines