QA Critical Utilities

**QA Critical Utilities - 5377 (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 Assurance - Critical Utilities **based in the **Stein**, **Switzerland**.

**Main Responsibilities**:

- Responsible for the GMP compliance of **critical utilities** (including but not limited to **clean water, clean steam, compressed gases**), **facilities** (including but not limited to **HVAC, clean rooms, cold rooms**), as well the **process support** (including but not limited to **autoclave**, **CIP/SIP**) during the project management lifecycle from design to qualification and validation to handover:

- Ensures that CQV plans of GMP systems are in place and executed by adhering to the client’s Quality policies and applicable SOPs.
- Ensures that selected vendors are qualified.
- Approves SOPs, CQV plans, protocols and reports as well as project related CQV documents (e.g. URS, FAT/SAT, etc.)
- Provide quality oversight on CQV documents as well as related change controls.
- Provide leadership and guidance to staff on qualification/validation issues.
- Manages deviations, changes and CAPAs/tasks in an open and timely manner, taking leadership for their resolution, but escalating when necessary.
- Ensures that decisions are fully supported by global and local Quality and Regulatory.
- Ensures that cGMP and guidelines are followed and implemented during the entire phase of the project from Ideation to Execution and handover.
- Participate in global/ inter-department quality initiatives.

**Qualifications and Experience**:

- **Relevant working/residency permit or Swiss/EU-Citizenship required.**
- Bachelor or Master's degree in Mechanical, Engineering, Biotechnology, Pharmacy or any other relevant areas
- Several years of experience in Engineering with a main focus on GMP critical utilities i.e. clean water, clean steam, compressed gases, clean rooms, and HVAC
- Significant experience in the GMP regulated pharmaceutical industry, preferably with a role in a Quality Unit
- SME in the area of critical utilities, qualification, validation and aseptic filling
- Sound understanding of aseptic fill-finish facility design.
- Ability to communicate with all kinds of interfaces within the organization and with regulatory agencies (Swissmedic, FDA, etc.)
- Fluent in English, German would be an advantage.
- Structured, organized, proactive and collaborative working attitude.
- Strong verbal and written communication skills