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 Josh Barnes on 021 4911066 or email

Firstname (required)

Surname (required)

Your Email (required)

Your mobile (required)

Upload CV (required)


In order to provide you with our services, we need to process certain personal information about you. We will only use your personal information to deliver the job-seeking or related services you have requested.

We seek your consent to store your data and provide you with the best possible service. If you have any questions regarding our legal obligations to you or your rights under the GDPR please refer to our privacy statement which clearly outlines all of your rights.

Related Articles

Biopharma Report

biopharma biopharmaceuticals industry report
Ensuring that the supply of qualified professionals is sufficient to meet demand will be the crucial step in successfully expanding the biopharma industry in Ireland. The EGFSN (Expert Group on Future Skills Needs) estimates that 5,000 additional staff will be employed in biologics manufacturing by 2020. The number of professionals employed in the production of traditional […]
Read More