Quality Assurance Manager C&q
Vor 3 Tagen
For a project at our client’s site, based in **Stein (AG)**, we are looking for an experienced
Quality Assurance Manager C&Q - Aseptic Fill-Finish Facility (w/m/d)
In this role, we are looking for someone who will be responsible for the Commissioning & Qualification (C&Q) compliance of an aseptic fill-finish drug product manufacturing facility CAPEX project, supporting the strategic investments of the company.
**Your Qualifications**:
- **Several years of experience in the GMP-regulated pharmaceutical industry, **preferably in a role within a Quality Unit
- **Bachelor’s or master’s degree in engineering, Life Sciences **or a related field
- **Experience in a Quality Assurance role for the C&Q of GMP systems related to aseptic fill-finish processes and facilities (filling equipment, lyophilization, clean utilities, and clean room facilities)**:
- **Fluent in English**, German would be an advantage
**Your Responsibilities**:
- Providing quality oversight and ensuring regulatory compliance for the assigned CAPEX project
- Ensuring C&Q compliance of GMP systems, including equipment, utilities, and facilities, throughout the project management lifecycle, from design engineering to the initial C&Q and handover phases
- Reviewing and approving C&Q documents for GMP systems, as well as managing changes and deviations
- Supporting audits and regulatory inspections by entities such as Swissmedic and FDA
- Offering leadership and guidance to project team members regarding C&Q strategy and addressing related issues
- Ensuring that decisions are fully supported by both global and local Quality, as well as Regulatory departments
- Proactively escalating issues in an open and timely manner, taking the lead in their resolution
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