Senior Quality Control Analyst

PE Global are looking for a NPI Senior Analyst on behalf of our client based in Dublin:

12 Month initial contract

The role:

PE Global is currently recruiting for an NPI Senior Analyst on behalf of a leading pharmaceutical company based in Dublin. This is an initial 12-month contract role.

Position Summary:

The individual in this position should have a strong working knowledge of the cGMP laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The NPI Senior Analyst is responsible for providing technical and laboratory support during method transfer and validation. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail.

The individual must be able to perform routine tasks with a minimum of supervision.

Responsibilities:

• Perform all lab functions in compliance with cGMP
• Follow written protocols for Transfer and Validation activities
• Troubleshoot new methods as required
• Ensure training is current for all job functions performed
• Provide QC SME and day to day technical guidance for NPI activities
• Support the NPI management team as required
• Lead and complete execution of investigations/CAPAs in a timely manner
• Training lead in specific assays overseeing the execution of all training activities for all new personnel
• Drive continuous improvement initiatives within the QC department

Education and Experience:

• BSc in Chemistry or a biological science, 4-7 years’ experience, or equivalent combination of education and experience.
• In depth knowledge of current regulatory requirements for Chemistry or Biochemistry methods in support of cGMP operations supporting clinical and commercial manufacturing
• Good technical knowledge in the area of Biochemistry or Chemistry.
• Good experience in investigation methodology and method troubleshootingg
• Ability to follow written procedures with close attention to detail
• Good report writing and technical writing skills.
• Ability to function with minimal supervision for routine job duties

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

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