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Validation Specialist

Validation Specialist

Lancesoft INCIndianapolis, IN, US
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Job Description

Job Description

Job Description :

The holder of this position is charged with supporting the critical aspects of operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements.

  • Writing and executing media protocols, procedures and guiding documents for isolator fill line readiness.
  • Provide guidance to manufacturing, working with the operator, focusing on manufacturing process and ensuring the quality and validation are in compliance with the requirements.
  • Provide expertise on conducting assessments on documentation related to supply products manufacturing to adhere to Client QM, QD and global regulations.
  • Interact / collaborate with Tech / Ops functions to facilitate transfer of knowledge and deliverables for the isolator fill line readiness.
  • Monitor, and report on Key Performance Indicators (KPI) and performance measures of the validation team members to enable strategic objectives to be met for isolator fill line readiness.
  • Understand, develop validation PQ approaches and perform PQ executions for the isolator fill line readiness.
  • Contribute to validation policies, guidance documents (SOPs, VMPs, CPPs) detailing best practice approach with isolator fill line project focus.

Academic / Technical Qualifications :

  • Bachelor’s Degree in a Science, Engineering or relevant discipline
  • 5+ years relevant pharmaceutical and / or validation / qualification experience

    • Specialist / Technical Qualifications :

  • Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment
  • Must be (or quickly become) familiar with the relevant areas of science applicable in area(s) of deployment
  • Must be (or quickly become) familiar with the general areas of Technical knowledge / understanding

    • Job Type : Contract

    Experience :

  • Pharmaceutical : 5 years (Required)
  • Validation / Qualification : 5 years (Preferred)

    • Education :

  • Bachelor's (Required)

    • Company Description

    We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

    Company Description

    We believe in service that helps you solve a problem, move forward with a project, manage a difficult situation, or simply check something off your list.

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