Global GMP Auditor (d/f/m)

Berufsbezeichnung:

Global GMP Auditor (d/f/m)

Unternehmen

Novartis

Stellenbeschreibung

Job Description Summary 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’ Sandoz!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. 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.Job DescriptionYour key responsibilities:Your responsibilities include, but are not limited to:

• Plan, lead, conduct, document, report, and follow-up of GMP audits according to the requirements specified in the respective Sandoz procedures as well as applicable regulations, standards, quality agreements, and guidance documents.
• Execution of audits according to the audit schedule
• Ability to meet audit report and CAPA Plan review timelines as defined in local SOPs
• Perform follow up and escalation activities as defined in local SOPs
• Support compliances activities as defined
• Audits will be focused to mid-low risk manufacturing and other GMP activities, on the basis of actual experience/expertise
• 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.
• Maintain current knowledge of regulations, standards, and guidance documents.

What you’ll bring to the role:Essential Requirements:

• Degree in Chemistry, Pharmacy, Biology, Engineering or another related science.
• Excellent oral and written English communication skills. Preferable: Good knowledge/mother tongue of an additional language (e.g. German, French, Italian or Spanish) is preferred.
• At least 10 years broad experience in Pharmaceutical or Medical Device Industry.
• The operational experience should include QA/QC management 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.
• Expertise in at latest, 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.
• Sound and practical judgement in the interpretation and application of regulations and standards

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!Imagine what you could do here at Sandoz!In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as 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 € 64.023,54/year (on a full time basis). In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies. We are open for part-time and job sharing models and support flexible and remote working where possible.Commitment to Diversity & Inclusion:We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.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:#SandozSkills Desired Auditing, Audit Management, Communication Skills, Compliance Audits, Compliance Risk, Continuous Learning, Dealing With Ambiguity, Decision Making Skills, Gmp Procedures, Inspection Readiness, Organizational Skills, People Management and Leadership, Qa (Quality Assurance), Regulatory Compliance, Risk Management, Self-Awareness, Technological Expertise

Erwartetes Gehalt

Standort

Kundl, Tirol

Jobdatum

Thu, 29 Aug 2024 00:18:42 GMT

Um uns zu helfen, unsere Rekrutierungsbemühungen zu verfolgen, geben Sie bitte in Ihrer E-Mail/Ihrem Anschreiben an, wo (jobsineu.net) Sie diese Stellenausschreibung gesehen haben.