Quality Assurance Manager (ldc)

Novartis UK

Latvia
Base: 33,000.00 eur gross annually; bonus/equity: ...
Gxp compliance
Batch documentation review
Quality investigations
Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs

Job Summary

  • Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.
  • Manage/Approve critical quality issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) according to the Quality Agreement and the Novartis Quality Manual.
  • Support launches of product in close collaboration with BDand L partner and/ or development organization.

Matching Summary

Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical / pharmaceutical products are in compliance with the Novartis Quality Manual, the effective Quality Agreement that they meet relevant GxP regulatory requirements and are conducted according to local SOPs.

Salary

Base: 33000.00 EUR gross annually; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • GxP compliance
  • batch documentation review
  • quality investigations
  • SOP development
  • regulatory requirements knowledge
  • continuous improvement

Nice-to-have

  • analytical thinking
  • collaboration
  • digital saviness
  • dealing with ambiguity
  • sense of urgency

Key Requirements

  • GxP Experience
  • Quality Management Systems
  • Deviation Management
  • Audit & Inspection Management
  • Batch Record Review
  • Corrective and Preventive Action (CAPA)
  • Change Control Management
  • Release Management
  • SOP (Standard Operating Procedures) development
  • Escalation Management
  • KPI Reporting

Work Rights

Not specified

Tailored Resume

Cover Letter