GMP Compliance Auditor (m/w/d)

Beginn

• Carry out job duties independently, including interpret, explain and apply applicable current regulations, guidelines, policies, and procedures for pharmaceutical products, medical devices, and regulated studies
• Independently plan and conduct internal system audits and external GxP supplier audits
• Maintain approved supplier list, global audit schedule and participate in supplier management processes
• Gather internal and external audit metrics and present to QA management for trend analysis
• Recommend plan of action for satisfactory resolution of quality and regulatory compliance issues
• Provide guidance and training on GxP regulations and guidelines to GxP auditors and functional areas personnel
• Assist GxP QA Management on the collaboration with the Inspection Management group on external audits by regulatory agencies and customers
• Develop / maintain and update departmental systems, procedures and records pertinent to position responsibilities
• Expected to elevate any issues to management, as necessary, in meeting these responsibilities. Leads goals with cross-functional or broader scope. Resolves project team issues with minimal oversight

Qualifications

• Bachelor’s degree preferably in life sciences or engineering
• Demonstrated strong leadership competencies, proficient level of technical capabilities, and independence. Proven track record utilizing core & technical competencies
• Thorough understanding of international GMP regulatory standards
• 5+ years experience in function or related fields such as:
• Quality Assurance / Regulatory Affairs
• Quality Assurance auditing experience (preferred)
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above
• Accreditation by a professional body is desirable (e.g. American Society for Quality (ASQ) Certified Quality Manager (CQM) and/or Certified Quality Auditor (CQA))