Quality Assurance Specialist

7 days ago


Portlaoise, Laois, Ireland Quanta Consultancy Services Ltd Full time
Job Description

In this role, you will be responsible for designing and implementing validation procedures to ensure the quality and consistency of pharmaceutical products. You will work closely with cross-functional teams to develop and execute qualification and validation plans.

About Quanta Consultancy Services Ltd

We are a leading consultancy specializing in pharmaceutical manufacturing and process validation. Our clients value our expertise and commitment to delivering high-quality solutions.

Responsibilities
  • Design and author qualification and validation documentation, including standard operating procedures (SOPs) and change control procedures.
  • Develop and execute execution plans for cycle development and performance qualification activities.
  • Collaborate with production, maintenance, and quality representatives to resolve technical issues during study execution.
  • Provide technical input into quality notifications by authoring, reviewing, and approving investigations.
  • Perform root cause analysis of system failures using standard tools and methods.
  • Suggest improvements through Lean Six Sigma methodologies.

Requirements
  • A degree in applied pharmaceutical or biological sciences, engineering, or a related field.
  • Experience in cleaning validation, including CD & PQ of mobile vessels and parts washers.
  • Exception/Deviation Management and Change Control experience.
  • Leading technical projects is essential.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial.


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