QA Specialist - Clean Utilities
Key information
- Publication date:18 November 2024
- Workload:100%
- Contract type:Temporary
- Language:English (Fluent)
- Place of work:Stein AG
Location: Stein, AG, Switzerland
Start Date: ASAP
Contract Duration: 6 months (with the possibility of extension)
Your Mission:
* Ensure GMP compliance for critical utilities (e.g., clean water, clean steam, compressed gases), facilities (e.g., HVAC, clean rooms, cold rooms), and process support systems (e.g., autoclave, CIP/SIP) throughout the project management lifecycle from design to qualification, validation, and handover.
* Oversee the development and execution of CQV (Commissioning, Qualification, and Validation) plans for GMP systems in alignment with Quality policies and Standard Operating Procedures (SOPs).
* Review and approve CQV plans, protocols, and reports, including project-related CQV documents (e.g., User Requirements Specifications (URS), Factory Acceptance Testing (FAT)/Site Acceptance Testing (SAT), Installation Qualification (IQ)/Operational Qualification (OQ)).
* Provide quality oversight on CQV documentation and manage related change controls.
* Lead and guide staff on qualification and validation issues, ensuring smooth execution of tasks.
* Manage and resolve Quality deviations, changes, and Corrective and Preventive Actions (CAPAs) promptly, while escalating issues when necessary.
Your Background:
* Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
* Significant experience in the GMP-regulated pharmaceutical industry, preferably in a Quality Unit role.
* Proven experience in a QA or Engineering role focused on Clean Utilities related to aseptic fill-finish processes and facilities.
* Fluency in English; German is an advantage.
What We Offer:
* An opportunity to work on impactful CAPEX projects within a leading pharmaceutical company.
* A dynamic role in ensuring the highest standards of GMP compliance.
* A chance to contribute to a dedicated team in Stein, AG with a focus on innovation and quality.
If you're a detail-oriented QA professional with expertise in Clean Utilities, we'd love to hear from you!
Apply now or reach out directly to Veronika von Mentzer, Recruiter: Write an email
Start Date: ASAP
Contract Duration: 6 months (with the possibility of extension)
Your Mission:
* Ensure GMP compliance for critical utilities (e.g., clean water, clean steam, compressed gases), facilities (e.g., HVAC, clean rooms, cold rooms), and process support systems (e.g., autoclave, CIP/SIP) throughout the project management lifecycle from design to qualification, validation, and handover.
* Oversee the development and execution of CQV (Commissioning, Qualification, and Validation) plans for GMP systems in alignment with Quality policies and Standard Operating Procedures (SOPs).
* Review and approve CQV plans, protocols, and reports, including project-related CQV documents (e.g., User Requirements Specifications (URS), Factory Acceptance Testing (FAT)/Site Acceptance Testing (SAT), Installation Qualification (IQ)/Operational Qualification (OQ)).
* Provide quality oversight on CQV documentation and manage related change controls.
* Lead and guide staff on qualification and validation issues, ensuring smooth execution of tasks.
* Manage and resolve Quality deviations, changes, and Corrective and Preventive Actions (CAPAs) promptly, while escalating issues when necessary.
Your Background:
* Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
* Significant experience in the GMP-regulated pharmaceutical industry, preferably in a Quality Unit role.
* Proven experience in a QA or Engineering role focused on Clean Utilities related to aseptic fill-finish processes and facilities.
* Fluency in English; German is an advantage.
What We Offer:
* An opportunity to work on impactful CAPEX projects within a leading pharmaceutical company.
* A dynamic role in ensuring the highest standards of GMP compliance.
* A chance to contribute to a dedicated team in Stein, AG with a focus on innovation and quality.
If you're a detail-oriented QA professional with expertise in Clean Utilities, we'd love to hear from you!
Apply now or reach out directly to Veronika von Mentzer, Recruiter: Write an email
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