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