Senior Quality Control Analyst

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Job Description

On behalf of my client, a global Biopharmaceutical company in Co. Cork, I am recruiting for a Senior Scientist in Analytical Operations.

The successful candidate will be tasked with independently planning and executing experiments that support routine & non-routine development activities and project goals. This is a permanent full-time position.

Responsibilities:
• Applies advanced level of understanding of analytical methods.
• May create API or drug product specifications
• Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
• Collation of data and technical writing for submissions for regulatory filings.
• Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
• Generation, review and approval of development & validation lifecycle documentation including change controls, risk assessments, protocols, reports etc
• Collation of data and technical writing for submissions for regulatory filings.
• Planning and execution of method transfer/validations, process, cleaning and analytical testing in accordance with validation protocols
• Manage group with multiple areas of responsibility and may lead a component of a project within the job family.
• Identifies and introduces new technology and/or methods to the organization and trains junior staff.
• 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)

Qualifications:
• Competent in the operation of Analytical Instrumentation including Dissolution Baths, KF, UPLC & HPLC proficient in LIMS & Empower etc.
• Bachelor’s degree or higher in Chemistry or Biology
• Minimum of 10 years’ relevant experience
• Resilient & dynamic profile with the ability to deliver in an ambiguous environment
• Ability to engage and manage multiple stakeholders to achieve the objective

If you are interested in applying for this role, please call Zoe on +353 1 2784671 or email zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com

 

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  • Salary:Negotiable
  • Location:Cork
  • Type:Permanent
  • Category:Science,Thornshaw
  • Ref.no:JO-2003-448305_63