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iso gmp capa fda regulatory compliance
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📋 Description

  • Manage quality assurance projects, validations, and process audits.
  • Lead technical investigations and CAPA resolution for critical issues.
  • Oversee process improvement initiatives for quality systems.
  • Author, review, and approve QA documentation and protocols.
  • Support regulatory and customer audit preparations and responses.
  • Advise cross-functional teams on quality requirements.

🎯 Requirements

  • Minimum 8 years QA experience with a bachelor's in a relevant field or equivalent.
  • English proficiency required.
  • Expertise in QA systems, validations, and regulatory compliance.
  • Advanced project management and technical analysis skills.
  • Leadership in root cause analysis and CAPA.
  • Outstanding documentation and reporting abilities.
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