Collins McNicholas

Role Responsibilities:

  • Batch Record Review & material release to ensure compliance with GMP requirements. 
  • Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints. 
  • Carries out tasks related to the management of batch records design and approval. 
  • Executes administration of the SAP Quality Management Module. 
  • Carries out tasks relating to the management of site change control systems. 
  • Compiles Annual Product Reviews. 
  • Supports all validation activities on site as described in the Site Validation Master Plan. 
  • Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.). 
  • Supports system qualification and process validation activities. 
  • Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance 
  • Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site. 
  • Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI) 
  • Perform GMP audits on-site and vendor facilities as required. 
  • Carries out tasks related to the administration of site supplier approval process.

Role Requirements:

  • Bachelor’s Degree in a scientific/technical discipline required 
  • A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. 
  • Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. 
  • Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities. 


  • Experience in auditing of external suppliers, contractors and vendors.

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email

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