Quality Engineering Specialist (6192)
Quality Engineering Specialist – 6192 ADA
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 Quality Engineering Specialist (QA Specialist, CSV & Automation) based in Stein, Switzerland for a 12-month contract with possible extension.
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 as part of the client’s CAPEX project portfolio.
Main Responsibilities:
You will be 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:
- Ensuring that qualification/validation plan and execution of equipment, infrastructure and computerized systems are in place by adhering to client’s Quality policies
- Approve SOPs, commissioning/qualification/validation protocols and reports as well as project related CQV / CSV documents (e.g. URS, FAT/SAT, etc.)
- Provide QA leadership, oversight and support to staff on qualification/validation topics related to ongoing projects and ensures that selected vendors are qualified
- Act 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.)
- Manage 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