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Cleaning Validation Specialist

Cleaning Validation Specialist

ScientificjobsCarlow
18 days ago
Job description

We’re currently recruiting for an exciting opportunity with a Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

  • Execute cleaning cycle development and PQ of equipment.
  • Writing and adhering to validation strategies, coordinating with outside vendors, writing protocols independently, sample submission, analysing test results, and preparing technical reports.
  • Execute run the business activities e.g. equipment periodic reviews, cleaning periodic review, CAPAs and deviations, change control, risk assessments.
  • Provide support during commissioning phase by reviewing and approving documents. Ensure documentation complies with standards.
  • Part-take in cross-functional problem-solving teams for troubleshooting and investigations within Vaccines IPT
  • Technical report writing, statistical analysis of data
  • Adherence to the latest regulatory guidelines.
  • Represent the IPT on cross-functional project teams.
  • Provide technical input and support and present as an SME on relevant topics during regulatory inspections.
  • Adherence to highest standards for Compliance (Quality and Safety)
  • Ensure compliance with site EHS policy, cGMP and other business regulations and support Technical IPT input to risk assessments, audits, regulatory inspections and incident investigations.
  • Ensure the highest Quality, Compliance and Safety standards by participating and complying with our Manufacturing Division Quality Management System (QMS) requirements, including ownership, as relevant.

Education & Experience

  • Experience as a validation specialist in a pharmaceutical or a 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.
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    Cleaning Validation Specialist • Carlow