Collins McNicholas

Job Title: Operations Compliance Specialist

 The Operational Compliance Specialist will work with the compliance group to maintaining all aspects of compliance within team. This includes GMP& EHS compliance. The leadership style is one of collaboration, coaching. This will require a substantial amount of his/her time within the various areas, engaging and communicating with all team members. 

Activities within Role: The Senior Compliance Specialist helps to molds the culture to one that supports a High Performance Organisation.

  • Supports the compliance plan and quality metrics generation
  • Complete review and approval of documentation 
  • Leads walk down and support audits
  • Participate in the preparation for and hosting of regulatory and customer audits
  • GMP training delivery to personnel
  • Investigation of Minor Deviations
  • Investigation of EHS Incidents
  • Provide Compliance guidance to Operating procedure 
  • Review Deviation trends and identify effective CAPA’s where necessary
  • Proactive monitoring of CAPAs to ensure holistic trends are proactively resolved 
  • Participates in the overall CAPA effectiveness programme and continued improvement on root cause analysis and follow-up CAPA 
  • Participates in Quality Risk Management and is facilitator and QRM Lead. 

 

 

Qualifications

5 years’ experience in pharmaceutical industry. 

>3 years’ experience in operation /Quality role.

Demonstrated technical knowledge and experience in compliance (GMP, Eng, Technical. Degree in (Science/Engineering) 

For a confidential discussion and more information on the role, please contact Eloisa Ruiz on 021 4809118 or email eloisa.ruiz@collinsmcnicholas.ie

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