Global GMP Senior Auditor

Global GMP Senior Auditor (d/f/m) | Kundl, Austria

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. By creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally. Join us, the future is ours to shape

Your Key Responsibilities:

Your responsibilities include, but are not limited to:

• 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 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 operations is critical to success.
• Provide technical guidance, mentoring and training on audit activities as well as 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 improvement 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. Maintain current knowledge of regulations, standards and guidance documents.
• Identify and report best practices and lessons learned to support development/training of GMP auditors.

What you'll bring to the role:

Essential Requirements:

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science (advanced degree preferred)
• Excellent oral and written English communication skills plus good knowledge/mother tongue of an additional language (e.g. German, French, Italian, Chinese or Spanish)
• At least 10 years broad experience in pharmaceutical or medical device industry, where the operational experience should include QA/QC management and manufacturing, 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 Manufacturing, 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 persuasion, used in obtaining cooperation and consensus with colleagues, vendors and customers.
• Sound and practical judgement in the interpretation and application of regulations and standards · Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
• Excellent leadership and facilitation skills

You´ll receive:

• Attractive salary with incentive program
• Modern company pension scheme
• Flexible working hours / home-office depending on the position
• 14 weeks of paid parental leave
• Additional days off (bridge-days)
• Subsidized meals in our canteen
• Sustainable mobility in the form of company transportation, shift buses and car sharing
• Company Kindergarden and summer camps for children
• Wellbeing & mental health offers
• Learning and development options for your personal and professional growth
• Worldwide career opportunities

In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position the minimum salary is EUR 78.383,9/year (on a full-time basis).

The actual salary will be significantly higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provides more than 800 million patient treatments to over 700 million patients every 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 are powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged

Are you ready to join us? Then we look forward to your application

Commitment to Diversity & Inclusion:

We are committed to building an outstanding, inclusive work environment and fostering diverse teams, that represent the patients and communities we serve.

If you require assistance during the application process due to a medical condition, physical disability, or a neurodiverse condition, please contact us at .

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