Quality Compliance Coordinator – Waterford | Collins McNicholas

Quality Compliance Coordinator – Waterford

  • Reference: CJ43519
  • Job Type: Contract
  • Location: Munster, Waterford
  • Category: Science, Pharmaceutical & Food

Reports To: Quality Systems Manager

Scope of Responsibility:

  • Process owner for L1 and L2 audit programme, and successful implementation of same on site.
  • Support Management Review/Quality Council.
  • Support Quality Audits Level 1, 2, 3 and 4 Inspection Readiness activity
  • Support CAPA Process and Quality Alert Process
  • Quality metrics
  • Familiar with Regulations (Medicinal and Medical Device)
  • Site Recall/PIRC procedure
  • Internal Halal Auditor
  • Supports site TIP projects as required
  • Continuous improvement in Quality team processes
  • Procedures review and approval
  • Quality Representative support to other departments
  • QMS Implementation support
  • Risk Management (support identified risks as required)

 

Quality Responsibilities:

  • Perform duties in a compliant manner and behave in accordance with our Quality Management System requirements
  • Participate fully in our site’s quality initiatives and ensure that all relevant quality standards are adhered to
  • Maintain GMP standards where appropriate to your role
  • Read and understand relevant Standard Operating Procedures and Global Quality applicable to role
  • Management Policies relevant to your job role
  • Attend training and complete assessments as required
  • Ensure Quality and GMP are at the forefront of changes proposed
  • Awareness of appropriate Directives, Standards, Quality Managements Systems related to the manufacture of Medical Device’s for required markets; As below
  • Medical Device guidelines
  • QMS company Policies and Procedures
  • Pharmaceutical Affairs Law Japan
  • EU GMP guidelines
  • Understanding of and ability to implement GPS initiatives
  • Ability to communicate with a wide variety of people at all levels both within the sites and the company and externally through appropriate skills: – Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening
  • Demonstrated ability to problem solve
  • Demonstrated ability to effectively plan work and to manage projects
  • Ensure Halal requirements are met in accordance with General Guidelines of Halal Assurance System LPPOM MUI for applicable Medical Device products / markets.

 

Education & Experience:

  • Third level education, science-based degree is preferable.
  • 2 years’ experience in pharmaceutical / healthcare industry preferably in a similar role.

 

Preferred Experience:                                   

  • Understanding of and ability to implement continuous improvement projects.
  • Ability to communicate with a wide variety of people at all levels both within the sites and the company and externally through appropriate skills: – Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening.
  • Familiarization with products manufactured in all Value Streams.
  • Thorough knowledge of site quality systems.
  • Demonstrated ability to problem solve.
  • Demonstrated ability to effectively plan work and to manage projects.
  • Understanding of Quality Managements Systems related to the manufacture of Medical Device and Medicinal products for required markets.

 

For a confidential discussion and more information on the role, please contact Emer on 021 4911061 or email emer.ocallaghan@collinsmcnicholas.ie

For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie

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  • Emer O'Callaghan
  • Recruitment Consultant
  • 0214911061
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