Global QA Compliance Manager (m/f/d)

Your Profile:

• At least 10 years' experience in the Pharmaceutical Industry; at least 3 years of auditing experience, Solid GMP/GDP auditing experience related to GMP, GDP or ISO for Pharma, preferable with experience in sterile manufacturing leading audits.
  
• Strong knowledge and understanding of the EU, FDA, PICs, WHO and other relevant GMP, GDP and ICH guidelines and regulations, including ISO 9001 and ISO 13485.
  
• Expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
  
• General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology,
  
• Capable of understanding and overcoming different cultural and language obstacles to provide solution that satisfy corporate, regional and local objectives.
  
• Self-motivation, flexibility and a high level of individual responsibility.
  
• Eagerness to learn and continuously improve.

Your Tasks:

• Plan, lead, conduct, report and follow up of Quality GMP/GDP audits at ACINO manufacturing sites and ACINO local/regional organizations as well as external aseptic and non-sterile and other GMP/GDP service providers according to ACINO procedures.
  
• Identify areas of risk and provide independent assessments on impact of audited activities.
  
• Assure permanent transfer of best practice identified during the audit into ACINO QMS system.
  
• Support the strategic development of an effective global risk-based audit strategy and program.
  
• Monitor the global annual external and internal audit plan.
  
• Maintain current knowledge of regulations, standards, and guidance documents.
  
• Lead the Global Escalation Management System within ACINO.
  
• Support the Inspection Readiness program at ACINO Sites/offices.
  
• Support maintenance and improvements of computerized Quality Audit Tools (Trackwise etc.)
  
• Establish and maintain global Directives and SOPs relevant for external and internal auditing.
  
• Understand quality by design and actively contribute to drive the improvement of the auditing process.
  
• Support the internal and external auditor qualification program.
  
• Identify and report best practices and lessons learned to support development/training of internal GMP/GDP auditors.

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