Collins McNicholas

Role Responsibilities:

QA Activities:

  • Responsible for facility compliance with regulatory commitments, in-house requirements and GMP.
  • Introduction of quality systems by means of research and assessment of current industry practices and GMP requirements.
  • Preparation of procedures and policies for area of responsibility.
  • Responsibility for maintenance and development of GMP awareness facility-wide, including: preparation and execution of training programmes, assessment of GMP training requirements, and execution of internal GMP auditing.
  • Investigation for QA review of all GMP critical documents.
  • Participate and manage in the introduction and maintenance of Global Quality Management Systems (GQMS)
  • In-house auditing.
  • Line clearance procedures.
  • Exception and deviation management e.g. deviations, Alarms, OOS, etc.
  • Documentary review.
  • Support quality aspects of materials management including supplier approval, supplier complaints and specification management.

 

Regulatory Activities:

  • Maintenance of site master file.
  • Preparation of annual reports and activities i.e. Product Quality Review, Mock Recall etc.
  • Trending of complaints.
  • Maintain manufacturing licence, variations etc.

 

Validation Activities:

  • Provision of support and assistance in execution and control of validation programmes.

 

General:

  • Carry out all activities in compliance with company Safety and Environmental Standard Operating Procedures.
  • Participate in team-based project work and plant-wide initiatives to improve the GMP compliance and financial performance of the Envision area.
  • Other duties as assigned supervision management.

 

Key eGMP Responsibilities:

  • Maintain, develop and manage QA systems.
  • Follow Standard Operating Procedures while carrying out duties at all times.
  • Participate fully in all GMP and operational programs and complete all Training Records in an accurate and timely manner.

 

Role Requirements:

  • At least 5 years’ experience in a GMP regulated environment.
  • Experience of scientific report writing including such documents as SOP’s, protocols, deviations, reports etc.
  • Ability to evaluate and assess information to determine appropriate risk and required actions is critical.

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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