Senior QA Specialist, QA Analytics 80-100% (f/m/d)

Tasks

• Ensure GMP compliance
• Ensure GMP compliance for stability testing
• Ensure pharmacopoeia compliance
• Release GMP relevant documents
• Represent QA concerns to QC and analytical development
• Review and approve CAPAs
• Review and approve SOPs
• Review and approve analytical methods and specifications
• Review and approve change controls
• Review and approve deviations
• Review and approve investigations
• Review and approve validation plans and reports
• Supervise OOS investigations
• Support inspections and audits

Perks/Benefits

• Benefits package
• Ethical workplace
• Inclusive workplace
• Relocation assistance

Skills/Tech-stack

Analytical Methods | Analytical method validation | Auditing | CAPA | CGMP | Change Control | Deviation Management | Document Control | European Pharmacopoeia | GMP | GxP | Investigation management | Japanese Pharmacopoeia | Method validation | OOX investigation | Out of Specification | Pharmacopoeias | Regulatory Compliance | S&OP | Stability Testing | USP | Validation