Senior Pharmaceutical Development Analyst

5 days ago


Co Armagh Northern Ireland, United Kingdom Norbrook Full time
Job Overview

The successful candidate will work as part of a cross-functional R&D team and gain a broad understanding of the processes involved in bringing new pharmaceutical products to market.

Key Responsibilities
  • Perform chemical and physical testing of R&D batches in relation to method development, validation, and transfer of finished product methods.
  • Develop, optimize, validate, and transfer finished product methods of analysis using various physio-chemical techniques in accordance with relevant standard operating procedures and regulatory guidelines.
  • Perform stability testing of R&D batches of finished product in line with current GMP and V/ICH requirements.
  • Assist in the collection of samples from production suites in support of development/pre-approval and process validation batches and perform analytical testing on same batches.
  • Trend analytical data and perform investigative analysis for out-of-specification results in accordance with company procedures.
  • Ensure all work is executed in accordance with Methods of Analysis, SOPs, protocols, and GMP guidelines.
  • Generate, interpret, and record data, results, draft methods, protocols, and reports pertaining to method development, validation, and transfer alongside stability studies and process validation of finished product.
  • Actively problem-solve, troubleshoot, and provide solutions to analytical challenges during testing of finished product methods.
  • Conduct departmental training in all validated finished product methods as part of the method transfer process.
Requirements

The successful candidate will be responsible for executing their daily tasks to meet overall project timelines and reporting results to a senior analyst in a timely and accurate manner.

The ideal candidate will have a strong understanding of pharmaceutical development processes and be able to work effectively in a team environment.

Norbrook Laboratories Limited is an equal opportunities employer and welcomes applications from all qualified candidates.



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