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  • Job reference number:15330344
  • Client ID:RI/RS 16338
  • Posted on:08-MAR-2018
  • Location:WATERFORD
  • Job type:PERMANENT

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

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