Process Scientist - Pharma
Process Scientist - Co. Waterford. Job Purpose: To ensure process validation activities are completed in line with internal and regulatory procedures and guidelines. Key Responsibilities: • 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 departments to ensure validation activities are 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. This job originally appeared on RecruitIreland.com.
271 days ago