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Global Supplier Quality Auditor Eu Region

4 months ago

Swindon, United Kingdom Catalent Full time

Catalent is a global, high-growth, a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

As an integral member of the Global Supplier Quality Management team, the **Global Supplier Quality Auditor** position will be responsible for performing Supplier Audits regionally and in accordance with their assigned schedule in support of supplier integrity and oversight. Performing audits, generation of audit reports and management of supplier CAPA to ensure required actions are completed within the required timeframe.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.

**The Role**
- Perform Supplier on-site audits or remote audits (as applicable) in accordance to the required standards to support the Supplier Management Central Program.
- Responsible for organizing and performing the audits assigned and to develop a planned audit schedule to maximize audits conducted during one trip i.e. grouped audits based on location.
- Work actively with the Catalent sites to manage and conduct Pre-Audit Preparation activities with an understanding of requesting sites risk assessment to ensure alignment to Global Standards.
- Ensure generation of audit reports, management of supplier response and CAPA. Work collaboratively with the supplier to assess and conclude acceptance of supplier identified CAPA are completed in the required timelines.
- Proactive assessment and identification of risk for mitigation and communication to stakeholders.
- Generate metrics to provide visibility of audits due, planned audit dates, Audits complete, Audit reports process timelines and overdue audits.
- Collation and communication of common finding categories to allow identification of risk areas across Supplier base.
- Proactive planning to ensure maintenance of audits assigned to mitigate overdues.
- Monitor and facilitate activities required to assure qualified status of existing and prospective suppliers in compliance with Global procedures and Regulatory requirements.
- Generate Global Quality Agreements in accordance to templates and liaise with site and Suppliers to finalize to allow Supplier Quality Director approval.
- Collaborate and foster cross-functional business relationships within Global functional groups such as Procurement, Sites and Supply Chain to ensure any risks are identified and communicated.
- Act as a liaison between suppliers and the quality teams globally during the management of supplier quality issues.
- Other duties as assigned.
- Bachelor’s Degree
- 2-5 years auditing experience
- Fluent English read, written and spoken.
- Certified auditor or lead auditor credentials preferred.
- Experience working in an auditing role within the Pharmaceutical/Medical Device industry.
- Knowledge and understanding of the following principles and guidelines: EU EudraLex Volume 4 GMPs, 21 CFR Parts 111/210/211 (FDA), ANVISA, ISO, and related International Regulations affecting pharmaceutical products and medical devices.
- Working knowledge of industry related guidelines such as ICH Q7, GHTF, and IPEC.
- Proven ability to identify, collaborate, and resolve supplier related compliance issues.
- Strong process improvement mindset.
- Ability to travel domestically and on occasion abroad to Supplier locations; Up to 50% travel.
- Ability to work independently and as part of a remote team.
- Excellent verbal and written communication and presentation skills

**Catalent’s standard leadership competencies that are used to interview and for Performance & Development**:

- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops

**Catalent offers rewarding opportunities to further your career** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. me