QA Manager - Milano, Italy | Biospace
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QA Manager

Amgen

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Location:
Milano, Italy
Posted Date:
7/21/2017
Position Type:
Full time
Job Code:
R-37790
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

Amgen is a values-based organization with a powerful sense of shared purpose toward our mission: to serve patients. We provide the capabilities, resources, and rewards of a global enterprise, while maintaining the entrepreneurialism and pioneering spirit that marked our early days as a biotechnology innovator. We encourage our team members to have fulfilling and meaningful careers through challenging assignments, career development, and valuable opportunities such as this: QA Manager.

We are looking for candidates with an excellent level of English (C1 or above) that would:

  • Be an integral quality member of Amgen quality contract manufacturing organization
  • Be the lead investigator for critical or major product impacting non conformances at the contract manufacturer
  • Review and approve Non Conformances and CAPA's
  • Identify and mitigate Risk at the CMO or testing Laboratories
  • Provide training to the CMOs in technical writing and how to conduct root cause analysis
  • Be a mentor to Quality site managers conducting investigations and writing good investigations/ deviation reports
  • Interaction with Amgen`s Global Compliance organization and Regulatory authorities during internal audits and inspections

You will also serve as a QA site manager with the following responsibilities:

  • Primary Quality Assurance point of contact for a given contract site or product
  • Manage CMOs to contractual obligations relative to Quality Agreement, assuring products continuously meet pre-defined regulatory requirements
  • Review and approve completed production batch records, Standard Operating Procedures, Work
  • Instructions and Forms as applicable
  • Review and approve all cGMP documents from CMOs or Contract Laboratories
  • Conduct Data Integrity assessment
  • Disposition drug substance, drug product, devices or packaged goods
  • Review and approve change control records as needed

Requirements

Requirements

  • Master's Degree in life science or (bio) medical sciences
  • Almost 3 years of laboratory or manufacturing experience
  • Previous experience in conduct deviation/ nonconformance investigation and root cause analysis
  • Availability to travel and to be eventually relocated

We would like to meet candidates with:

  • A belief that together we can tackle almost any problem
  • A strong desire to get involved within the industry as well as the community at large
  • Hold a forward-thinking mentality and a courage for calculated risks
  • Characteristics such as reliability, honesty, and integrity
  • A devotion to improving the world through inspiring actions

A Fortune 150 company operating in nearly 100 countries around the world, we invest in highly skilled, dedicated and collaborative individuals who are ready to contribute to our mission in meaningful ways and make a difference in the lives of our patients.

That's why, as a member of the Amgen team, we provide you with valuable opportunities to broaden your experience and maximize your potential. We ensure our staff are equipped to excel today and tomorrow by leveraging state-of-the-art technologies and modern working environments, encouraging open dialogue and professional debate, and collaborating with world-class talent and institutions around the globe. We believe in rewarding those who do rewarding work and are committed to providing careers that can help turn the tide of serious, life-interrupting illnesses.