Qualification and Validation Consultant, V.I.E

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Posted 7 months ago

Job description:

As a consultant, you will work with our clients on the following missions:

  • Provide QA oversight of commissioning, qualification and validation activities to GMP manufacturing facility.
  • Hands on experience with Validation methodology (FAT, SAT, IQ OQ, PQ)
  • Responsible for managing the review/approval of design and commissioning documentation, validation protocols, reports and support records to certify compliance with specifications and procedures.
  • Review and assist in investigating deviations related to manufacturing process equipment, utilities, automation, computer systems, validation, methods and laboratory instruments.
  • Responsible for performing change control assessments and reviewing/approving change control implementation plans for process, equipment, utilities, method and computer system validation.
  • Responsible for supporting internal and external inspections for Quality Assurance Validation.
  • Must have strong understanding of Computerized and Automated Systems Validation Engineering lifecycle.

Required profile:

  • Bachelor’s Degree in Science or related technical field.
  • Minimum of 2+ years of Quality Assurance/Validation experience in pharmaceutical industry.
  • Experience in IT systems, automation, operations and manufacturing within the pharmaceutical industry and in new manufacturing facility start-up environments is required.
  • Must have demonstrated understanding of cGMP.Strong understanding of QA principles, industry practices, and standards with demonstrated ability to apply these to GMP operations is required.

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