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Project Manager - Qualification and Validation

Project Manager - Qualification and Validation

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Project Manager - Qualification and Validation

  • Location:

    England

  • Sector:

    Technical Operations - Pharma

  • Contact:

    Glen Fairbrother

  • Salary:

    Negotiable

  • Job type:

    Temporary

  • Contact email:

    pharmajobs@msigroupltd.com

  • Job ref:

    VR/04002_1663659927

  • Published:

    over 1 year ago

  • Duration:

    10 Months

  • Startdate:

    ASAP

Large Pharma client near Bern Switzerland require an experienced Quality Control Qualification and Validation Specialist PM for a mission critical project.

The initial contract will be until the end of year, but likely to extend

Main Responsibilities:
● Managing the project(s) of equipment qualification and Windows 10 migration within the Quality Control department
● Responsible for the communication & coordination of project related activities, ensuring adherence to budget and timelines
● Support & coordination of computerized & non-computerized system qualification and validation activities
● Perform and/or support the writing of specification documents (URS) & system impact assessments (SIA)
● Review test protocols, plans and reports
● Support test execution
● Supporting the timely and effective completion of investigations, change controls and CAPA's

Qualification:
● Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
● Several years of experience in project management including the use of the relevant tools (MS Project, project dashboards etc.)
● Able to coordinate activities between different stakeholders and departments
● Experience in the qualification of equipment (computerized/non-computerized) in a GMP environment and good knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11,...)
● Good understanding of analytical technologies
● Strong analytical thinking and problem-solving ability
● Excellent communication and teamwork skills
● Good verbal and written skills in English, German is a plus

Please contact MSI for further details