Collins McNicholas

Our client is recruiting for a Data Reviewer to join their growing R&D Analytical Team. Reporting to the R&D Analytical Team Leader, this role will be based in the R&D Centre in Waterford.

Responsibilities

  • To review all data associated with the development, transfer or validation of robust, sound analytical methods
  • To review test methods, validation protocols and reports as applicable.
  • To prepare submission documentation in support of license applications.
  • To take part in /lead Laboratory Investigations.
  • To attend internal project review meetings as required
  • To assist in the preparation for customer/ regulatory inspections
  • To identify and make recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • To review raw data from the testing of raw materials, in-process samples and finished products in a timely & efficient manner to ensure quality and efficacy of the product.
  • 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 review all data to ensure that it is completed correctly, in line with data integrity guidelines, free from errors, omissions or defects in order to achieve a high level of customer service and cGMP
  • To perform additional team tasks as agreed to support effective running of the Business.
  • To support all other on-going laboratory functions & requirements.

 

 

Qualifications & Experience

  • Qualified to a minimum of degree level in Analytical Chemistry, Pharmaceutical Science or a related discipline.
  • At least five years’ experience working in a related technical environment.
  • Good problem-solving abilities.
  • Proficient in the use of HPLC & associated problem solving.
  • Working knowledge of Empower laboratory software.
  • Proficient in dissolution testing
  • Proficient in Technical report writing

             

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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