QA Specialist, CSV

vor 15 Stunden

Stein, Aargau, Schweiz CTC Resourcing Solutions Vollzeit

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a
QA Specialist, CSV & Automation
for a
one year
contract role
based in the
Stein Switzerland
.

QA Specialist, CSV & Automation – 6785 ASH

The QA Specialist, CSV & Automation is responsible for the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment and utilities related to the GMP manufacturing of drug products

Main Responsibilities:

  • Responsible for the compliance of commissioning and qualification of large CAPEX projects (e.g. new drug product facility) from ideation to execution phases, throughout all design phases Ensures that qualification/validation plan and execution of equipment, infrastructure and computerized-systems are in place
  • Approves SOPs, commissioning/qualification/validation protocols and reports as well as project related CQV / CSV documents (e.g. URS, FAT/SAT, etc.)
  • Provides QA leadership, oversight and support to staff on qualification/validation topics related to ongoing projects and ensures that selected vendors are qualified
  • Acts as first point of contact within GQE for any area related to the lifecycle and compliance for equipment, infrastructure and computerized-systems qualification/validation, including documentation in shared global systems (e.g. Kneat, Trackwise, DMS, Unifier, etc.)
  • Manages Quality deviations, changes and CAPAs/tasks in an open and timely manner, taking leadership for their resolution, but escalating when necessary

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • Bachelor or Master's degree in Engineering, Life Sciences or related field
  • Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit
  • Experience in a QA role for the CSV / Automation of GMP systems related to aseptic fill-finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities)
  • Fluent in English, German would be an advantage

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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