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Alphanumeric Systems

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PV Operations QMS Support Principal Scientist

Research ScientistResearch ScientistFull TimeRemoteLeadTeam 201-500Since 1979H1B No SponsorCompany SiteLinkedIn

Location

India

Posted

107 days ago

Salary

0

Seniority

Lead

Bachelor Degree3 yrs expEnglishGCPHashiCorp Vault

Job Description

PV Operations QMS Support Principal Scientist

Alphanumeric Systems

• Manage PV non‑conformances and CAPAs, including conducting investigations (using recognised techniques), documenting outcomes, and ensuring timely closure. • Support the QMS with metrics, trend analysis, and risk indicators. • Perform metric calculations using Power BI dashboards, validating outputs through agreed filters and late‑case reconciliation, and prepare presentations where required. • Serve as QA SME for GVP, GCP, GMP as they relate to safety data. • Collaborate cross‑functionally to ensure high‑quality, compliant documentation and processes, while effectively managing workload and coordinating key deliverables using strong project‑management skills. • Support trending analyses with third‑party vendors and internal stakeholders. • Escalate PV operations issues to appropriate PV management. • Contribute to global PV operations process improvements to reduce repeat issues. • Ensure data integrity across safety systems, documentation repositories, and workflow platforms.

Job Requirements

  • A minimum of a bachelor’s degree in a life science, nursing, or a related field (e.g., pharmacology, biochemistry) is required or previous experience equating to educational requirements.
  • At least 3-5 years of core PV (case processing) experience.
  • A minimum of 1–2 years of experience in quality management, including activities such as performing root cause analysis and related quality/compliance oversight.
  • Extensive experience in operational risk assessment, quality issue management, root cause analysis, corrective and preventative action (CAPA) development and tracking and audit/inspection preparation.
  • Knowledge of PV vendor management.
  • Familiarity with global PV regulations (FDA, EMA, ICH).
  • Experience in clinical trial and post–marketing PV.
  • Strong communication, problem–solving, and organizational skills.
  • Experience with SOP development, process review, and PV/clinical/regulatory documentation.
  • Good documentation practices and stakeholder management skills.
  • Ability to map complex PV processes and manage document updates through quality systems.
  • Experience with PV systems specifically Argus, and Veeva Vault Safety.

Benefits

  • 100% remote from India

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