GCP Quality Auditor

Amgen; Portugal; Presencial; EUR 50 000 - 70 000; Tempo integral

Resumo da oferta

A leading global biopharmaceutical company in Portugal seeks a GCP Quality Auditor to plan and conduct compliance audits internationally. The ideal candidate will hold a Bachelor's degree in a scientific discipline and have extensive GCP auditing experience. Join a team committed to innovation and healthcare advancement with flexible work arrangements and generous benefits.

Serviços

Generous Amgen Total Rewards Plan

Flexible work arrangements

Diverse and inclusive community

Qualificações

• Bachelor’s degree in a scientific discipline, medical sciences or pharmacy qualification.
• Proven and extensive international auditing experience in GCP.
• Excellent written and verbal English communication skills.

Responsabilidades

• Plan, conduct and report routine and directed GCP compliance audits internationally.
• Serve as a lead auditor for complex GCP audits.
• Identify and communicate compliance risks to R&D Quality management.
• Host and/or play a role in regulatory authority inspections.
• Contribute to or lead R&D Quality process improvement initiatives.

Conhecimentos

International auditing experience in GCP

Data mining and manipulation

Excellent written and verbal English communication skills

Formação académica

Bachelor’s degree in a scientific discipline

Descrição da oferta de emprego

Join our team at Amgen Capability Center Portugal, the #1 company in Best Workplaces™ (201–500 employees category) by the Great Place to Work Institute. With over 400 talented individuals from more than 40 nationalities, our Lisbon center thrives at the intersection of innovation, excellence, and inspiration. This is your opportunity to explore the future of healthcare through technology and digital innovation, supporting our mission To Serve Patients.

What you will do

You will be joining Amgen’s R&D Quality Audit Team of expert, professional and widely experienced individuals working with a global remit across Amgen’s portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgen\'s R&D Quality Group.

In this vital role as GCP Quality Auditor within R&D Quality you will be planning and participating in global audits of Amgen’s clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities.

Responsibilities

• Plan, conduct and report routine and directed GCP compliance audits internationally
• Serve as a lead auditor for complex GCP audits
• Identify and communicate compliance risks to R&D Quality management
• Host and/or play a role in regulatory authority inspections
• Contribute to or lead R&D Quality process improvement initiatives
• Author and contribute to the development of R&D Quality cross functional controlled documents

The role can entail up to 40% travel to international destinations.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:

• Bachelor’s degree in a scientific discipline, medical sciences or pharmacy qualification
• Proven and extensive international auditing experience in GCP
• Experience of data mining, manipulation and data analytics would be advantageous
• Excellent written and verbal English communication skills

Preferred Requirements

• Postgraduate qualification
• Experience supporting regulatory authority inspections
• Participation in process improvement initiatives

Thrive – What you can expect of us

• Vast opportunities to learn, develop, and move up and across our global organization.
• Diverse and inclusive community of belonging, where colleagues are empowered to bring ideas to the table, take risks, and act.
• Generous Amgen Total Rewards Plan comprising healthcare, finance, wealth and career benefits.
• Flexible work arrangements.

Apply now

Objects in your future are closer than they appear. Join us. CAREERS.AMGEN.COM

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.