Global GMP Senior Quality Auditor

Job Description Summary

Global GMP Senior Quality Auditor

Job Description

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

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 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!

The future is ours to shape!

Join our Sandoz Network - If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Sandoz and our career opportunities, join the Network here: https://talentnetwork.novartis.com/sandoztalentpool

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Skills Desired

Agility, Agility, Auditing, Audit Management, Business Acumen, Business Partnering, Collaboration / Teamwork, Communication Skills, Compliance Audits, Continued Learning, Dealing With Ambiguity, Decision Making Skills, Employee Performance Evaluations, Finance Acumen, Gmp Procedures, Goal-Oriented, Health Authorities, Inspection Readiness, Leadership, Logical Thinking, Major Incident Management, Organization Skills, People Management, Problem Solving Skill, Problem Solving Skills {+ 5 more}