Collins McNicholas

Role Responsibilities:

  • To support the Head of Quality and the R&D Quality Assurance Manager & Team Lead with the quality assurance function.
  • Support R&D with QA support including but not limited to the following:
    • batch documentation review
    • assessment of manufacturing events from a QA perspective.
  • Electronic Documentation Management System
    • Check own work and that of others for accuracy before / prior to ‘QA Authorisation’ of documentation.
    • QA reviewer of Process Compliance Change Controls
    • Progress Process Compliance actions and attach evidence as required.
  • Perform internal audits as scheduled.
  • Review and approval of Regulatory deficiency responses.
  • To ensure that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Report any safety or compliance issues as per company procedures.
  • Attend Product review meetings and provide support on the development of new Products
  • Liaise with regulatory affairs/ formulations / laboratory personnel to ensure regulatory and quality requirements are met.
  • Assist with review of Submission Documentation in support of license applications and customer requirements.
  • Noncompliance reporting and corrective action / continuous improvement implementation.
  • Operation of SAP Quality function as per procedures.
  • Support the on-going OOS/IR/CACI closeout programme.
    • Complete any assigned actions in the agreed time frame.
    • Investigate any incident assigned in a timely fashion.
    • Review deviation investigations and actions as required.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Health & Safety
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
    • Report any hazards



Minimum Qualifications and Experience:

  • BSc (Require Quality Management as a part of degree)
  • Minimum of 2 – 4 years QA experience in a GMP compliant role
  • Experience with desktop and internet-based software applications (e.g. electronic document management system, MRP system) an advantage but not essential.
  • Excellent communication and presentation skills
  • Focus on quality and detail
  • Careful planning to achieve accurate and timely results
  • Ability to define and manage own tasks and schedules
  • Experience performing and assessing risk/impact assessment an advantage
  • Sterile manufacturing experience would be of benefit


Skills & Behavioural Competencies:



  • Demonstrates a high level of Technical understanding.
  • Motivated
  • Drives continuous improvements
  • Ability to multi-task



  • Proficient at review of EudraLex chapters and CFR 21 parts 210 and 211
  • Leading investigations and OOS’s
  • Leading GMP and Quality impacting training site wide
  • Experience with process and method validation review and equipment qualification
  • Implement and review Major change controls and associated Risk Assessments.
  • Coordinate and lead customer complaint investigations
  • Lead auditor trained
  • Provide QA oversight to projects
  • Provide training to level 1 officers and interns 
  • Risk assessments and regulatory compliance implementation and interpretation.
  • Perform Gap Assessments between current procedures and related guidance’s
  • Work to assigned goals


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

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