Global GMP Senior Quality Auditor

Global GMP Senior Quality Auditor

Sandoz

Warsaw, Poland

Job responsibilities:

• Support the strategic development of an effective global risk-based audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
• Plan, lead, conduct, document, and follow-up of GMP audit according to the require-ments specified in the respective Sandoz Quality procedures as well as applicable regu-lations, standards, quality agreements, and guidance documents.
• For this role, auditors will be given more complex and higher-risk audits, such as sterile API, aseptic DP, and combination products. The ability to assess risk of these opera-tions is critical to success.
• Provide technical guidance, mentoring, and training on audit activities.
• Provide regulatory guidance for timely remediation and recommendations regarding acceptability of the proposed filing.
• Prepare audit reports according to Sandoz requirements and timelines.
• Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to Sandoz requirements on Management Escalations and other relevant procedures. Ensure adequate definition and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with the stakeholder QA representative and Auditee.
• Act as GMP compliance consultant for GMP trainings, task forces, continuous improve-ment projects as needed. Assure permanent transfer of best practice identified during the audit into Sandoz QMS system
• Review and advise on relevant policies and procedures.
• Mentor junior GMP staff as required.
• Maintain current knowledge of regulations, standards, and guidance documents.
• Identify and report best practices and lessons learned to support development/training of GMP auditors.

Job requirements:

• Education: Degree in Chemistry, Pharmacy, Biology, Engineering or another re-lated science

Work Experience:

• At least 10 years broad experience in Pharmaceutical or Med-ical Device Industry.
• The operational experience should include QA/QC manage-ment and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority.
• 3 years auditing experience preferred, and excellent knowledge of regulatory requirements.
• Willingness to travel approximately 60% of the time.
• Expertise in at least one of the following areas: DP Manufac-turing, Laboratories activities, Medical Devices, API, Excipients, Sterile, Biologics, Microbiology, Computer System Validation, Packaging activities, Quality Systems.
• Experience and/or interaction with local Health Authority and sporadically with other Health Authorities.
• Strong interpersonal skills, including diplomacy and persua-sion, used in obtaining cooperation and consensus with Sandoz colleagues, vendors and customers.
• Sound and practical judgement in the interpretation and ap-plication of regulations and standards
• Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision
• Excellent leadership and facilitation skills

Apply Now

More Job Searches

Poland      Manufacturing and Logistics      Medical Devices      Quality Assurance      Sandoz