Collins McNicholas

Job Purpose:

To support Product Development, Commercial Supply and Stability by ensuring all components, raw materials and finished products are tested in accordance with cGxP.

 

Role Responsibilities:

  • To review raw data from testing of components/raw materials/finished products / stability in a timely & efficient manner.
  • To manage and control all raw data presented for review and file once completed.
  • To complete required release documentation including stability summary sheets.
  • Trending of API, finished product and stability testing.
  • Complete investigations in a timely and efficient manner where applicable.
  • Identify and action recommendations for improvements.
  • Implement 5S and Lean lab initiatives.
  • To support all other on-going laboratory functions & requirements.
  • 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.
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To assist in the preparation for customer/ regulatory inspections. 
  • Health & Safety:
    • Implement safety requirements as per site documentation including SOPs, Safety Statement and COPs
    • Report any defects
    • If unsure about safety requirements – ask

 

Role Requirements:

  • Qualified to a minimum of degree level.
  • At least two years’ experience working in a related technical environment.

 

Skills:

  • Analytical Test Methods – Creation and Review
  • Operation of HPLC
  • Operation of GC, FT/IR
  • Computer Skills/Excel etc.

Behaviours:

  • Teamwork & Collaboration
  • Safety Awareness
  • Customer Focus
  • Quality Orientation
  • Problem Solving / Analysis
  • Innovation
  • Initiating Action
  • Adaptability
  • Project Management

 

For a confidential discussion and more information on the role, please contact Aisling on 021 4809118 or email aisling.lane@collinsmcnicholas.ie

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