Job Purpose: To ensure process validation activities at EirGen Pharma are completed in line with internal and regulatory procedures and guidelines
- Write and execute protocols and reports for the validation of new and existing processes. Including, but not limited to:
- Process Validation protocols
- Validations reports
- Continuous Process Validation Reports
- Compile summary reports based on executed protocols, following good documentation practices report structures.
- Liaise with contractors/ customers when external resources are required to complete validations.
- Liaise with relevant EirGen departments to ensure validation activities and planned and executed in line with applicable deadlines.
- Assist with the generation of metrics for the Technical Services department
- Assist with submission/ deficiency responses activities when required, in a timely manner.
- Draft/ revise/ review SOPs.
- Analyse statistical data to verify acceptable criteria.
- Develop testing strategies and rationale for manufacturing processes.
- Provide technical support/troubleshooting for process and equipment issues. • Apply cGMP guidelines to all aspects of validation.
- Investigate/resolve deviations associated with validation studies.
Minimum Qualifications & Experience
- Degree in an engineering or science discipline.
- Experience and knowledge of any or all of the following is desirable: Process validation Statistical packages, e.g. Minitab Analytical techniques Pharmaceutical solid dose manufacturing