QA Specialist
Vor 2 Tagen
Safeguard quality, shape compliance, and power the future of aseptic manufacturing. Join one of Proclinical's clients as a Quality Assurance Specialist and help safeguard the integrity of aseptic manufacturing. In this role, you'll drive compliance for equipment and computerized systems, ensuring GMP processes meet the highest standards. As part of major CAPEX initiatives, you'll lead commissioning, assessment, and verification efforts while facilitating adherence to quality and regulatory frameworks. Please note that to be considered for this role you must have the right to work in this location or hold an EU passport. Responsibilities: Ensure compliance of commissioning and qualification activities for large CAPEX projects, including new drug product facilities. Develop and oversee qualification and validation plans for equipment, infrastructure, and computerized systems. Approve SOPs, commissioning/qualification/validation protocols, and project-related CQV-CSV documents (e.g., URS, FAT, SAT). Provide QA leadership and guidance on qualification and validation topics for ongoing projects. Act as the primary QA contact for lifecycle and compliance matters related to equipment, infrastructure, and computerized systems. Manage documentation in shared global systems such as Kneat, Trackwise, DMS, and Unifier. Address quality deviations, changes, and CAPAs in a timely manner, escalating issues when necessary. Key Skills and Requirements: Academic background in Engineering, Life Sciences, or a related field. Experience in a GMP-regulated pharmaceutical environment, preferably within a Quality Unit. Expertise in QA for CSV and automation of GMP systems, particularly in aseptic fill-finish processes, facility filling equipment, lyophilization, clean utilities, and clean room facilities. Proficiency in English; German language skills are advantageous.
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QA Specialist, CSV
Vor 3 Tagen
Stein AG, Schweiz Coopers Group AG VollzeitQA Specialist, CSV & Automation m/f/d, Aargau The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within CAPEX project portfolio. Acting as a key Quality partner from project ideation through execution, this...
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QA Specialist, CSV
Vor 3 Tagen
Stein AG, Schweiz Coopers Group AG VollzeitQA Specialist, CSV & Automation m/f/d, Aargau The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within CAPEX project portfolio. Acting as a key Quality partner from project ideation through execution, this...
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QA Specialist, CSV
Vor 2 Tagen
Stein AG, Schweiz Coopers Group AG VollzeitQA Specialist, CSV & Automation m/f/d, Aargau The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within CAPEX project portfolio. Acting as a key Quality partner from project ideation through execution, this...
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QA Specialist, CSV
Vor 3 Tagen
Stein, Aargau, Schweiz CTC Resourcing Solutions VollzeitOur 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 aQA Specialist, CSV & Automationfor aone yearcontract rolebased in theStein Switzerland.QA Specialist, CSV & Automation – 6785 ASHThe QA Specialist, CSV & Automation is responsible for...
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QA Specialist, CSV Automation
Vor 3 Tagen
Stein, Aargau, Schweiz Hays VollzeitFor our international pharma client we are looking for aQA Specialist, CSV Automation (m/f/d).Duration: 12 months (possibility of extension)Workload: 100%Location: SteinResponsibilitiesEnsure qualification/validation plans and execution of equipment, infrastructure, and computerized systems in line with Quality policies.Approve SOPs, CQV/CSV protocols and...
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QA - CQV/CSV Specialist
Vor 2 Tagen
Stein am Rhein, Schweiz Panda International VollzeitKey Accountmanager- I help leaders in Life Sciences scale their teams with top talent Position: QA Specialist – CSV & Automation Overview The QA Specialist, CSV & Automation is responsible for ensuring full GMP compliance for the qualification and validation of equipment, computerized systems, infrastructure, and utilities supporting aseptic drug product...
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QA - CQV/CSV Specialist
Vor 5 Tagen
Stein am Rhein, Schaffhausen, Schweiz Panda International VollzeitPosition: QA Specialist – CSV & AutomationOverviewThe QA Specialist, CSV & Automation is responsible for ensuring full GMP compliance for the qualification and validation of equipment, computerized systems, infrastructure, and utilities supporting aseptic drug product manufacturing. This role supports large CAPEX projects across all lifecycle phases, from...
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QA Specialist
Vor 2 Tagen
Stein (AR), Schweiz Proclinical Group VollzeitSafeguard quality, shape compliance, and power the future of aseptic manufacturing. Join one of Proclinical's clients as a Quality Assurance Specialist and help safeguard the integrity of aseptic manufacturing. In this role, you'll drive compliance for equipment and computerized systems, ensuring GMP processes meet the highest standards. As part of major...
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QA Specialist, CSV
Vor 2 Tagen
Stein, Schweiz Coopers Group GmbH VollzeitContract duration: 1 yearLocation: SteinResponsibilitiesOversee and ensure qualification and validation compliance for equipment, infrastructure, and computerized systems associated with aseptic drug product manufacturing and related utilities.Provide QA support for major CAPEX projects (e.g., new drug product facilities), ensuring quality requirements are...
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QA Specialist: CSV
Vor 2 Tagen
Stein am Rhein, Schweiz Actalent VollzeitA leading staffing company is looking for a Quality Assurance Specialist in Switzerland to manage compliance in qualification and validation of GMP systems. The ideal candidate has a Bachelor's or Master's in Engineering or Life Sciences. Responsibilities include developing validation plans, approving documentation, and providing QA support on projects....
