Experienced QA Specialist
Core
Lead auditor and quality system specialist ensuring compliance with EU-GMP regulations for non-sterile API manufacturing.
Role type
Senior QA Specialist (Compliance)
Builds
Quality management systems (QMS) and regulatory compliance processes for pharmaceutical active ingredients.
Domain
Pharmaceutical manufacturing / Life Sciences
Required skills
Lead Auditor training, GMP compliance, risk assessment, CAPA management, computerized system validation, document control
Preferred skills
Microbiology, Chemistry, or Pharmaceutical background
Technologies
Computerized systems (GxP)
Responsibilities
Plan and execute internal and external audits, drive QMS development, review and approve quality documents, manage deviations and CAPA cases, represent QA in projects and contract negotiations, ensure compliance of computerized systems
Seniority
Senior, hands-on IC
