Snr Quality Compliance Analyst

Job Summary

Supporting the Biologics Development project.  It involves the establishment of a third-party quality system for the management of Contract Manufacturing Organizations for the commercial launch of new biologic product.

Supervisory responsibility:

  • Generation of a quality system and procedures for Third Party management
  • Establish Quality System audits and schedules for the supply chain
  • Generation of product launch documentation
  • Participate in Quality Launch Team meetings
  • Review and approve quality system records associated with Third Party quality launch

Education and Experience

  • Bachelor’s degree required in a science or engineering discipline….
  • Minimum 5 years’ experience in a quality discipline in pharma/medical device environment
  • Demonstrated knowledge of quality standards and regulations
  • Experience of working as part of internal and external teams to deliver projects

Essential Skills, Experience, and Competencies:

  • Demonstrated knowledge of validation processes and guidance’s
  • Proven to be self-directed and self-motivated
  • Excellent communication skills managing external partner companies

Problem solving ability using risk based decisions

Your Recruitment Consultant is Sean Winstanley

Sean Winstanley
Sean joined Arcon Recruitment in early 2018 as our Specialist Technical Recruiter. Originally from the UK, now settled in Ballaghadrereen, Sean brings a wealth of recruitment experience in the IT / Technical arena. Sean has developed excellent skills account managing international, high profile clients solving their recruitment dilemmas.