QA Specialist - Clean Utilities
Infos sur l'emploi
- Date de publication :18 novembre 2024
- Taux d'activité :100%
- Type de contrat :Temporaire
- Langue :anglais (Courant)
- Lieu de travail :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
By applying for this position, I consent to the Swisslinx Group of companies:
- storing my personal information (including name, contact details, Identification and CV information etc.) on their internal or external servers for the purpose of informing me of potential employment opportunities
- using my personal information or
- supplying it to third parties upon express consent for the purpose of informing me of potential job opportunities
- transferring where applicable my personal information to a country outside the EEA/EFTA
I also hereby agree to the Swisslinx privacy policy (http://www.swisslinx.com/en/legal/privacy-policy) and Terms of Use (http://www.swisslinx.com/en/legal/disclaimer)
