QA Coordinator | Collins McNicholas

QA Coordinator

  • Reference: CJ43276yy
  • Job Type: Permanent
  • Location: Munster, Waterford
  • Category: Science, Pharmaceutical & Food

Job Purpose

The purpose of this role is to embed RCA/CAPA processes to achieve a transformational reduction in deviations and safety incidents and to provide real time on the floor Quality support to the operations teams.


Breadth/ Scope of Accountability:


Scope of Responsibility (primary deliverables expected of the role)

  • Providing hands-on support to production that that drives culture change, i.e. strengthening the site continuous improvement culture and intolerance for deviations from operators through to the Site Leadership Team.
  • Coaching and mentoring site staff to drive alignment of site processes and procedures with QMS (e.g. GQMP 1007, 1000a and 6007A)
  • Working with other site teams, e.g. OE, GPS, Quality Operations and Technical to improve the effectiveness of site RCA/CAPA processes and progress culture change.
  • Facilitate, coach and mentor teams and individuals to build site capability in the RCA and CAPA processes.
  • Liaising with other sites and Central Quality with the interpretation, implementation and ongoing improvement of the RCA/CAPA analysis tools and processes.
  • Trend analysis of Deviations to identify priority deviations for elimination (target “big Wins”) and drive a transformational reduction in site incidents and deviations
  • Assisting the site to move to a proactive approach of incident prevention from a reactive approach of incident assessment and management
  • Good understanding of Gemba with a Purpose and the ability to perform, train, and coach this tool
  • Completion and coaching of self inspections assuring repeat issues are prevented
  • Drive inspection readiness to ensure the site is ‘audit ready every day’
  • On the floor support of Operations staff by Quality organization
  • To deputize for the OQ Shift Team Leader as required.


Impact of role on business objectives:

  • Ensure there is an effective problem solving system in place to prevent recurrence of issues and therefore reduce waste.
  • Be the focal point of problem solving within the Value Streams when the situation demands it to ensure on-time resolution of issues to support batch release.
  • Understand all Quality systems and ensure that product is made to appropriate GMP standards.


Environmental Health & Safety (EHS) Responsibilities:


Scope of Responsibilities

  • Perform duties in a compliant manner and behave in accordance with site SOP’s, EHS standards and guidelines and relevant legal requirements.
  • Read and understand Standard Operation Procedures applicable to role.
  • Report all accidents, incidents and any EHS issues using the appropriate process /system to your line manager or, if required, the Occupational Health Advisor.
  • Maintain work area in an inspection ready state and clean as you go to maintain good safe housekeeping standards.
  • Be aware of the impact of your job activities on EHS issues.


Quality Responsibilities:

Scope of 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.
  • Assess/investigate the data on products failing to meet requisite standards and reject or rework as appropriate.
  • Influence Quality Improvement (QI) programmes in conjunction with the appropriate Business Unit and technical departments that will reduce rejects and customer complaints. Lead QI activities within Operational Quality.
  • Approve and monitor all quality-related systems, procedures and documentation utilized within own area and aligned Business Unit.
  • Ensure that any changes have been appropriately validated and documented using the company recognized systems of approval.
  • Ensure that the Operational Quality Manager and other Business Unit Management (as applicable) are notified of any trends/changes or deviations from GMP, which may have significant effect on product quality.
  • Maintain GMP standards where appropriate.
  • Read and understand relevant Standard Operating Procedures and Global Quality applicable to role.
  • Attend training and complete assessments as required.
  • Ability to communicate with a wide variety of people at all levels both within the sites and externally through appropriate skills: – Verbal / written, Negotiation, Report writing, presentation, Empathy / affiliation and listening.



Specialised Knowledge

Basic Education

Third Level Science based certificate or 5+ years experience working in a similar role.


Preferred Education

Third level science-based diploma or higher degree.


Basic Experience

2 yrs experience in a pharmaceutical/ healthcare company.


Preferred Experience

Understanding of appropriate directives, standards, policies and guidelines and ability to implement appropriately,

• Directive 2001/83/EC



• cGMP (CFR 210/211,820)

• Facility and Process Guides

• MDD (93/42/ EEC)

• ISO 13485: 2012 and ISO 13485:2003

• MHLW Ordinance No 169

• MHLW Ordinance No 179

• MHLW Ordinance No 2

Understanding of relevant regulatory requirements for all markets..

Expected level of application of Knowledge High level of knowledge required to understand the production processes and all Quality systems on site and to ensure they are appropriately used.


For a confidential discussion and more information on the role, please contact Rory Walsh on 021 4911063 or email

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

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Rory Walsh

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  • Rory Walsh
  • Cork Regional Manager
  • 021 4809118
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