Quality Assurance Manager (ldc)

Novartis

Latvia
Base: 33,000.00 eur gross annually; bonus/equity: ...
Gxp regulatory compliance
Batch documentation review
Deviation and complaint management
Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical/pharmaceutical products comply with Novartis Quality Manual and GxP regulatory requirements

Job Summary

  • Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical/pharmaceutical products comply with Novartis Quality Manual and GxP regulatory requirements.
  • Lead investigations for noncompliance, manage critical quality issues, and escalate as necessary following Novartis policies.
  • Plan and implement GxP training programs, support product launches, and maintain coordinated contact with regulatory authorities and stakeholders.

Matching Summary

Ensure that all aspects of the handling, manufacturing and distribution of biopharmaceutical/pharmaceutical products comply with Novartis Quality Manual and GxP regulatory requirements.

Salary

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

Skills & Requirements

Must-have

  • GxP regulatory compliance
  • Batch documentation review
  • Deviation and complaint management
  • Corrective and Preventive Action (CAPA)
  • Quality Management Systems
  • Audit and inspection management
  • Change control management

Nice-to-have

  • Analytical thinking
  • Continuous improvement mindset
  • Leadership skills
  • Collaboration
  • Digital saviness
  • Sense of urgency
  • Problem solving skills
  • Communication skills
  • Data saviness
  • Risk management
  • Dealing with ambiguity
  • Regulatory requirements knowledge
  • Data integrity

Key Requirements

  • Experience with deviation management
  • Audit and inspection management experience
  • Batch record review expertise
  • CAPA knowledge
  • Quality assurance experience
  • GxP experience
  • SOP development experience
  • English language proficiency

Work Rights

Not specified

Tailored Resume

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