R&D Technicial Compliance Specialist

Galway

Basic Summary:

This role is responsible for reviewing & approving all analytical data for the R&D departments within Chanelle.

 

Key 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 projects

The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

 

Qualifications:

  • 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.
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R&D Technicial Compliance Specialist

Galway