Global Senior Pharmacovigilance (PV) Auditor

Global Senior Pharmacovigilance (PV) Auditor

Sandoz

Warsaw, Poland

Job responsibilites:

• 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 PV audit according to the requirements specified in the respective Sandoz Quality procedures as well as applicable regulations, 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 PV compliance consultant for PV trainings, task forces, continuous improvement projects as needed. Assure permanent transfer of best practice identified during the au-dit into Sandoz QMS system.
• Review and advise on relevant policies and procedures.
• Mentor junior PV 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 PV auditors.

Job requirements:

• Education (minimum/desirable): Degree in Chemistry, Pharmacy, Biology, Engineering or another re-lated science
• Languages: Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. Ger-man, French, Italian, Chinese, or Spanish) is preferred.

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.
• Three 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

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