Pharmaceutical Development Analyst

Hays


Date: 1 week ago
City: Newry
Contract type: Full time
Your new role

Responsibilities

You will work as part of the R&D team and gain a strong understanding of the process to bring new pharmaceutical products to market, by performing chemical and physical testing of R&D batches in relation to method development, validation and transfer of finished product methods as well as process validation and stability study testing. You will also be responsible for the execution of daily tasks to meet overall project timelines and report results to a senior analyst in a timely and accurate manner. Activities include:

  • Adopting a GMP approach at all times and be mindful of data integrity requirements when recording of data.
  • Perform stability testing of R&D batches of finished product all in line with current GMP and V/ICH requirements.
  • Ensure all work is executed in accordance with Methods of Analysis, SOPs, protocols, and GMP guidelines
  • Assist in the collection of samples from the production suites in support of development/pre-approval and process validation batches and perform analytical testing on same batches.

What You'll Need To Succeed

  • Educated to degree level in a science-related discipline.
  • Previous experience working in/exposure to a cGMP environment.
  • HPLC, UPLC, GC and practical wet chemistry experience.
  • Knowledge of VICH guidance for Method Validation of Finished product methods and Process validation and Stability studies.

What You Need To Do Now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.

#4620735 - Harry Resendez

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