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Analytical Operations Manager

Quality & Laboratory
Claire McGuckin
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Job Reference: JO-2009-65372_1599578735


I am currently recruiting for a Senior Analytical Scientist to join our Cork based well-established and growing Biopharma client. This is a Senior role that will join the QC function and lead projects on site.

Role Responsibilities

· Applies advanced level of understanding of analytical methods.

· Selects appropriate methods and techniques in performing methods development.

· Independently plans and executes experiments that support routine & non-routine development activities and project goals.

· May create API or drug product specifications.

· Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc

· Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols

· Works independently and determines methods and techniques on new or difficult assignments.

· Works on complex problems where analysis of situations or data requires comprehensive evaluation of many factors.

Role Requirements

· 10 + years experience in a similar role

· Method Validation, Project Management and Analytical instrumentation experience

· Working knowledge of GMPs, pharmacopoeial, regulatory requirements for analytical testing, phase appropriate standards for method validation.

· Advanced knowledge of current Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (GMPs).

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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Claire McGuckin
Claire McGuckin
Business Unit Lead
Quality & Laboratory
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