PROCESS VALIDATION ENGINEER PHARMAWATERFORD

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ICDS RECRUITMENT

  • 24 UPPER FITZWILLIAM STREET
  • DUBLIN 2
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  • Job reference number:15312271
  • Client ID:RI/RS 16117
  • Posted on:12-JAN-2018
  • Salary:NEGOTIABLE
  • Location:WATERFORD
  • Job type:PERMANENT

Process Validation Engineer Co. Waterford

Job Purpose:

To ensure process validation activities are completed in line with internal and regulatory procedures and guidelines

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 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

Other Information

Skills and Behavioural Competencies

Outstanding verbal and written communication skills. Must be able to work effectively as part of a team or on own initiative.

Excellent Communication Skills, Team Player, Attention to detail, Compliance

This job originally appeared on RecruitIreland.com