Details

Contract

Full-Time

Location

Neuchatel, Switzerland

Department

Life Sciences

Openings

1

Job ID

37481488

Senior GxP Compliance Auditor – Neuchatel, Switzerland Be a part of a revolutionary change. At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products with the power to improve the lives of a billion smokers worldwide. We’re also exploring new categories, looking beyond nicotine to develop a new portfolio of innovative products. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. It’s so rare in R&D that everything aligns to create the ideal conditions for outstanding work. Right now, at PMI, that’s exactly what’s happening. R&D is the driving force for our bold new vision: to replace cigarettes with a revolutionary portfolio of alternative products. Join us and you’ll have the resources, support and technology you need to break new ground and see ideas come to life. You’ll be surrounded by some of the brightest scientists in their fields, with fast access to subject experts and commercial decision-makers. If you’re creative, courageous and ready to take risks, you can make a huge impact and propel your career in an endless number of directions. Ultimately, by delivering our smoke-free and beyond nicotine future, your work could change the lives of millions. Your ‘day to day’ The Senior GxP Compliance Auditor will lead Quality Compliance audits and oversights according to ISO Standards, Good Laboratory Practice (GLP), Good Clinical Laboratory Practices (GCLP), Good Clinical Practices (GCP), Quality Management System (QMS) and other relevant standards and regulations, as well as executing the established Audit Program. More specifically, you'll • Plan and execute a risk-based review of sites to establish the annual audit programme, identifying risks and opportunities to the auditee, monitoring and updating heat map risk register in line with business evolution and audit feedback, monitoring of changes in the process and the organization, reviewing of previous audits outcome, and execution of audits in the Audit Programme. • Plan, execute and report audits and Facility inspections, raise potential critical observations to Quality Management, ensure that audit survey is completed for each audit, review for continuous improvement, provide support to Audit Coordinators and Lead Auditors. Review and approve audit CAPA plan, ensure timely audit / CAPA closure, and update the status in the programme. Establish and maintain metrics for KPI reporting. • Support the implementation of QMS, ensure continuous improvement, that the QMS Audit Package is aligned using applicable Audit Management Tools, review audit templates, ensure Auditor pool is up to date, establish and deliver auditors training, maintain relevant materials and supervise system access. • Act as SME for the IT Systems definition & improvement used to support Audit process performance and related audit management systems and tools by establishing, defining and maintaining a harmonized audit process, reviewing system's documentation related to validation, testing and usage as end-user, ensuring changes on system's functionalities and validation in accordance to computerized systems validation processes, and support Audit Community on the usage of the systems. • Support always inspection readiness (AIR), participate and/or conduct mock inspection audits, review of open CAPA and ongoing Action Plan from previous inspections, collaborate with the Manager AIR Quality Compliance and with any other Audit Coordinators. Who we’re looking for • BSc or MSc in Technology / science / engineering or equivalent. • Substantial experience in Pharmaceutical or Life Sciences, and of audit in GxP areas. Sound knowledge of compliance of Computerized System. Preferably has Lead Auditor certification in ISO9001, or ISO 17025, or ISO 13485, GMP or other relevant auditor certification. • Good Knowledge of Quality Management System (QMS), IT systems supporting audit process performance and relevant quality standards (GLP, GCLP, GCP, ISO, GMP) • Demonstrated communication and negotiation skills, confirmed ability to lead and influence others, good Organizational skills and Project Management expertise. • Fluent in written and spoken English is required. French and other languages would be an advantage. What we offer Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: • Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. • Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong. • Pursue your ambitions and develop your skills with a global business – our staggering size and scale provides endless opportunities to progress. • Take pride in delivering our promise to society: to improve the lives of a billion smokers. #LIJobs

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