GCP Quality Auditor
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Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Career Category
QualityJob Description
Join our team atAMGEN Capability Center Portugal number 1 company in Best WorkplacesTMhttps:// in Portugal in 2024 (category 201-500 employees) by the Great Place to Work Institute. We have a team of over 500 talented people and more than 40 different nationalities diverse areas of expertise and professional experience that are shaping the future of healthcare. This is your chance to explore a world of opportunities in different areas such as Cybersecurity Data & Analytics Digital Technology and Innovation Finance General & Admin Human Resources Regulatory Affairs and many Lisbons city center our AMGEN office fosters innovation excellence and inspiration. Come thrive with us at AMGEN supporting our mission To Serve Patients. What we do at AMGEN matters in peoples lives.
GCP QUALITY AUDITOR
LIVE
WHAT YOU WILL DO
You will be joining Amgens R&D Quality Audit Team of expert professional and widely experienced individuals working with a global remit across Amgens portfolio in all stages of development and post marketing. The R&D Quality audit team is part of Amgens 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 Amgens clinical trials activities. You may also support regulatory inspections of clinical sites and Amgen facilities.
The responsibilities of the role will include:
- 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.
WIN
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:
Minimum requirements
- Bachelors 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.
Objects in your future are closer than they appear. Join us.
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.
Key Skills
- Quality Assurance
- Quality Inspection
- Calipers
- ISO 9001
- Quality Audits
- Process Mapping
- Fair Housing Regulations
- Quality Control
- Underwriting
- cGMP
- As9100
- Manufacturing
About Company
Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the ... View more
