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Global Gmp Auditor
hace 3 meses
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.
This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' SandozAre you ready to make a difference?
Role Purpose
Lead, support and report independent GMP audits according to the Sandoz Quality System and the current GMP regulations to assess compliance with applicable regulations, standards, and guidance documents.
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.Your Key Responsibilities
- Support the strategic development of an effective global riskbased audit strategy and program. Collect, collate, and incorporate input into the audit strategy and plan.
- Plan, lead, conduct, document, and followup 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.
- 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 followup 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.
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
- Degree in Chemistry, Pharmacy, Biology, Engineering or another related science. Advanced degree preferred
- At least 45 years of experience in Pharmaceutical or Medical Device Industry, and 12 years auditing experience preferred.
- Excellent knowledge of regulatory requirements.
- Willingness to travel approximately 60% of the time
- The operational experience should include QA/QC management and manufacturing, or development or other relevant experience e.g. working at a regulatory health authority
- 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 Sandoz colleagues, vendors and customers.
- Fluent in English written and spoken, other languages are a plus
You'll receive:
Breakdown of benefits received in this role. Include flexible working, learning and development opportunities as well.
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.
Sandoz #SandoIberia
- Division
- SANDOZ
