Process Development Lead

2 weeks ago


Limerick, Limerick, Ireland Life Science Recruitment Full time

Our client, a leading global medical devices company, is now seeking a Process Development Lead to join their team in Limerick. This is a challenging role that requires a high level of expertise in process development and implementation, particularly in the area of CMC.

About the Position

The successful candidate will have a strong background in process development and implementation, with experience in leading cross-functional teams to develop and implement processes that meet regulatory requirements.

Key Responsibilities
  • Develop and implement processes that meet regulatory requirements.
  • Lead cross-functional teams to develop and implement processes.
  • Collaborate with stakeholders to identify contract manufacturers and API vendors.
  • Provide technical review of data and reports for accuracy and consistency with regulator's expectations.
  • Support the Investigation / Root Cause Analysis of OOS API results ensuring consistency in terms of methodology and regulatory expectations.
Requirements
  • Bachelor's degree, Masters or PhD in engineering/science or a related field.
  • Minimum of 7 years' relevant experience with process development and implementation.
  • Strong knowledge of medical device quality standards ISO13485/FDA practices and GMP, GLP or similar regulated industry standards.
  • Familiarity with FDA, US Pharmacopeia and/or European Pharmacopeia and ICH CMC regulatory topics.
  • Proven analytical and problem-solving skills.


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