Senior Quality Auditor, Global GMP
Kerr Dental
full-time
Posted on:
Location Type: Office
Location: Barcelona • Spain
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Job Level
About the role
- Lead, support and report independent GMP audits according to the Novartis Quality System and the current GMP regulations.
- Review and approve corrective action plans in support of the audit observations.
- Conduct and document GMP audits according to the requirements specified in the respective Novartis Quality procedures as well as applicable regulations and standards.
- Prepare audit reports according to NVS requirements and timelines.
- Provide technical guidance, mentoring, and training on audit activities.
- Mentor junior GMP staff as required.
- Ensure appropriate escalation to responsible management in case of critical findings and support immediate follow-up measures according to NVS requirements on Management Escalations and other relevant procedures.
Requirements
- 12+ years broad experience in Pharmaceutical or Medical Device Industry.
- 3 years auditing experience preferred, and excellent knowledge of regulatory requirements.
- Strong knowledge of GMP regulations, sound and practical judgement in the interpretation and application of regulations and standards.
- Solid operational experience, that should include QA/QC management and manufacturing, development or other relevant experience e.g. working at a regulatory health authority.
- Strong experience in Sterile and/or expertise in at least one of the following areas: DP Manufacturing, Laboratories activities, Medical Devices, API, Biologics, Microbiology, Computer System Validation, Quality Systems, Cell&Gene therapy, Radioligand therapy.
- Strong interpersonal skills, including diplomacy and persuasion, used in obtaining cooperation and consensus with Novartis colleagues, vendors and customers.
- Ability to independently manage and objectively evaluate complex compliance issues with minimal supervision.
- Fluent English, written and spoken. Other languages are a plus.
Benefits
- You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
- Commitment to Diversity and Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP regulationsauditingQA/QC managementComputer System ValidationSterile manufacturingDP ManufacturingLaboratories activitiesMedical DevicesAPIBiologics
Soft Skills
interpersonal skillsdiplomacypersuasiontechnical guidancementoringindependent managementobjective evaluationcommunication