Global Senior Pharmacovigilance (PV) Auditor

Job Description Summary

Lead, support and report independent PV audits according to the Sandoz Quality System and the current PV regulations to assess compliance with applicable regulations, standards, and guidance documents. Review and approve corrective action plans in support of the audit observations. The audits performed include internal and external targets of manufacturing sites, development centers, quality systems, contract manufacturers, laboratories, warehouses, country organizations, and suppliers.
Ensure alignment with strategic direction of the company and assist in driving implementation of the applicable actions. Provide consultation to Sandoz business units through risk-based assessments. Act as SME for assigned areas of responsibility.

 

Job Description

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

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum and entrepreneurial spirit is powered by an open, collaborative culture d