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Cleaning Validation

  1. France
Toulouse
  1. Contract
Competitive
  1. Commissioning, Qualification and Validation
35874

This vacancy has now expired

Cleaning Validation of Drug Substance Equipment - 6 Months Contract - South of France 

Are you looking for your next contract, and fancy the opportunity to work in the South of France? Our client, a global biotechnology organisation, are recruiting for a Cleaning Validation to join their team in the construction of their new biopharmaceutical production plant. This new build facility will be vital vehicle in helping our client continue global access to life changing therapeutics.


Role and responsibilities:
  • 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.
  • Technical report writing, statistical analysis of data
  • Adherence to the latest regulatory guidelines.
  • 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.

Requirements:
  • 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.

 If this role is of interest to you, please apply now! 

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