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Details

Research and Development Compliance Specialist


Reference:ANYG-747027 Location: Galway
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed

Research and Development Compliance Specialist
Our Galway based client are currently recruiting for an R&D Compliance Specialist role to join their team on a permanent basis. The successful candidate will be responsible for reviewing & approving all analytical data for the R&D departments within the organisation.
R&D

Responsibilities
• Review and approve the analytical data for the Pilot batches testing and the process validation. Ensure the data is correct and no deviations made
• Review and approve the method validation protocols and reports
• Review and approve the analytical method transfer protocols and reports
• Review and approve the stability reports for the optimization and pilot batches and ensure the data is reported accurately
• Review and approve the COAs
• Review and approve specific reports prepared for the regulatory submission by cross-referring to the raw data
• Co-ordinate with registration team for responding to the queries from regulatory agencies and customers
• Support R & D team in responding to the queries received from the regulatory agencies
• Review and approve the working standards preparations and ensure they are used within the shelf life and no deviations made
• Maintain the log of Dissolution and HPLC and any other instruments’ calibration and ensure that the calibrations are performed as per the schedule. If required address the technical issues
• Review HPLC data by logging into empower and ensure GLP is followed.
• Preparation of Bulk hold time study protocols
• Review the analysts’ logbooks and approve the data
• Review and approve the deviations/OOS for the Development project

Requirements
• Degree in Science Discipline or equivalent
• 5 – 10 years’ experience within the pharmaceutical industry in the relevant field
• Sound knowledge of empower/GMP/GLP
• Strong time management and organisational skills


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252