Validation Expert

4 days ago


Limerick, Limerick, Ireland Life Science Recruitment Full time

This is an exceptional opportunity to work with a renowned Pharmaceutical organization in Cork, Ireland. The successful candidate will be responsible for executing various tasks to ensure compliance with industry standards.

Key Responsibilities:
  1. Execute cycle development, cleaning validation, and performance qualification of equipment.
  2. Develop and adhere to validation strategies, collaborate with external vendors, write protocols independently, submit samples, analyze test results, and prepare technical reports.
  3. Execute routine business activities such as equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
  4. Support the commissioning phase by reviewing and approving documents ensuring compliance with industry standards.
  5. Participate in cross-functional problem-solving teams for troubleshooting and investigations within the Vaccines IPT.
  6. Prepare technical reports, perform statistical analysis of data.
  7. Adhere to the latest regulatory guidelines.
  8. Represent the IPT on cross-functional project teams.
  9. Provide technical input and support, present as an SME on relevant topics during regulatory inspections.
  10. Ensure adherence to highest standards for Compliance (Quality and Safety).
  11. Ensure compliance with site EHS policy, cGMP and other business regulations, support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
Education and Experience:
  • Experience as a validation specialist in a pharmaceutical or highly regulated environment and a B.Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
  • Experience in at least three of the following areas: C&Q validation, Cleaning Validation, Equipment validation, Process operations or manufacturing, Process Engineering.
  • A working knowledge of the GxP systems associated with this role would be advantageous. These include but are not limited to: GLIMS and eVAL, electronic batch records.

For more information about this opportunity, please contact us directly.


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