Senior GXP Auditor

Location
Cambridge, Massachusetts
Posted
Oct 11, 2021
Ref
R-08803
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time

Title:

Senior GXP Auditor

Company:

Ipsen Biopharm Ltd

Job Description:

An exciting opportunity has arisen for a GxP (GMP/GDP focus) Quality Auditor to join our dynamic Global Audit team. 

The jobholder will be accountable for scheduling, conducting, and reporting internal and external GxP audits with a focus on GMP/GDP regulations medical devices and food supplements.

The position requires expertise in a broad range of audits with demonstrable experience in sterile and biological manufacturing processes. The role encompasses a broad range of audit types eg: API, Drug Product, sterile processes, packaging, quality control, distribution, commercial operations and quality systems and will involve both on site and remote auditing as routine. Travel will be required internationally.

They will be a strong team player and experienced lead auditor able to manage an audit team for more complex audits. They will require expertise in written and oral communication in English and must be able to produce robust audit reports and findings.

To be successful in this role, you will have:

  • Bachelors degree in a scientific or health-related field
  • Lead auditor qualification/certification
  • Demonstrable experience of a minimum of 5 years auditing experience across all entities and systems for GMP/GDP
  • Must have expertise in audits of sterile and or biological manufacturing
  • Minimum 5-10 years’ experience in Quality within the pharmaceutical sector
  • Proven excellent written and verbal communication

IPSEN is committed to equality of opportunity for all staff and applications, individuals are encouraged to apply regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships.