Join a Leading Biopharma Company as a Quality Engineering Specialist!
On behalf of our client, a multinational company in the pharmaceutical, biotechnology, and nutrition sectors, we are looking for QA Specialist (CSV & Automation) 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 CAPEX project portfolio in Stein, AG.
Contract Type: Contract
Start Date: ASAP
Location: Stein
Workload: 100%
Duration: 1 year
Your mission:
Responsible for the compliance of commissioning and qualification of large CAPEX projects (eg new drug product facility) from ideation to execution phases, throughout all design phases:
Ensure that qualification/validation plan and execution of equipment, infrastructure and computerized systems are in place by adhering to the company's Quality policies
Approve SOPs, commissioning/qualification/validation protocols and reports as well as project related CQV/CSV documents (eg 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 life cycle and compliance for equipment, infrastructure and computerized-systems qualification/validation, including documentation in shared global systems (eg 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
Your background:
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
What's on Offer?
An opportunity to prove your expertise in a leading global company.
Be part of a dynamic team and a positive company culture.
If this sounds like you, don't hesitate to apply here or reach out directly to Veronika von Mentzer, Recruiter: (see below)
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