Quality Control Specialist

70

Not specified
5-8 years quality control experience
Gxp and cgmp regulatory knowledge
Iso 13485:2016 standard expertise
Galderma is seeking a Quality Control Specialist to uphold GMP compliance and enhance quality standards within their QC operations. The ideal candidate should have substantial experience in Quality Control or Quality Assurance, strong knowledge of regulatory guidelines, and the ability to collaborate effectively with various stakeholders

Job Summary

  • The role involves ensuring the QC department operates in full accordance with GMP requirements and regulatory guidelines.
  • You will lead and support deviation investigations, change controls, and QC acceptance activities while collaborating closely with Subject Matter Experts.
  • The position requires preparing for and supporting audits and inspections while driving continuous improvements of the quality system.

Matching Summary

Match Score: 85

Galderma is seeking a Quality Control Specialist to uphold GMP compliance and enhance quality standards within their QC operations. The ideal candidate should have substantial experience in Quality Control or Quality Assurance, strong knowledge of regulatory guidelines, and the ability to collaborate effectively with various stakeholders.

Skills & Requirements

Must-have

  • 5-8 years Quality Control experience
  • GxP and cGMP regulatory knowledge
  • ISO 13485:2016 standard expertise
  • EudraLex Volume 4 Part 1 compliance
  • 21 CFR Part 11, 211, and 820 knowledge
  • Deviation investigation and change control
  • Fluent in Swedish and English

Nice-to-have

  • Strong analytical and structured approach
  • Proactive improvement mindset
  • Ability to influence and educate teams
  • Cross-functional collaboration skills
  • Experience with SME support roles

Key Requirements

  • Bachelor's degree or equivalent
  • 5-8 years regulated industry experience
  • Fluency in Swedish and English
  • Knowledge of ISO 13485 and EudraLex
  • Experience with 21 CFR regulations

Work Rights

Not specified

Tailored Resume

Cover Letter