Collins McNicholas

Role Responsibilities:

  • Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met. 
  • Partners with other departments to ensure that compliance systems are implemented in an efficient manner. 
  • Supports the development and management of GMP compliance systems through the following activities: 
  • Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site. 
  • Assesses compliance systems on ongoing basis to identify opportunities for process improvement. 
  • Keeps abreast of regulatory compliance trends. 
  • Internal Audit Program 
  • Management of the document management system- which can include supporting and advising Documentation Control administration personnel, as required 
  • GMP service providers program 
  • Managing the nonconformance system and CAPA process 
  • Quality agreement process 
  • Change control process and system 
  • Supporting site regulatory inspections where appropriate 
  • Supporting the site induction process 
  • Metrics and report generation from the quality systems 

 

Role Requirements:

Essential:

  • The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required) 
  • A minimum of 3-5 years’ experience within the biological and/or pharmaceutical/ medical device industry 
  • Knowledgeable of FDA/EMEA regulatory requirements Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities 

Desirable: 

  • Experience of managing project groups or leading teams 
  • Skilled in the use of problem-solving tools/techniques 
  • Experience with systems such as Trackwise and electronic documentation management systems will be a distinct advantage 

 

Key Competencies Required:

  • Collaboration and teamwork 
  • Strategic thinker 
  • Problem-solving and attention to detail 
  • Results and performance driven 
  • Coaching and mentoring style 
  • Integrity, trustworthiness and objectivity 
  • Customer focus 
  • Clear communication skills
  • Adaptable and flexible 
  • Inclusive, facilitative style 
  • Builds strong productive relationships 
  • Seeks opportunities to grow and develop professionally 
  • Uses best practices to improve business operations  

For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie

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