QA Specialist, CSV
vor 21 Stunden
Contract duration: 1 year Location: Stein, Aargau, Switzerland 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 the CAPEX project portfolio. Acting as a key Quality partner from project ideation through execution, this role safeguards adherence to GMP standards across all design and implementation phases. The QA Specialist provides oversight for qualification and validation activities, supports project teams with expert guidance, and ensures that systems, equipment, and infrastructure meet quality policies and regulatory expectations. Responsibilities Oversee 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 embedded from concept through design and execution phases. Ensure that qualification/validation strategies, plans, and execution activities comply with quality policies and applicable regulations. Review and approve commissioning, qualification, and validation documentation, including SOPs, URS, FAT/SAT protocols, validation protocols, and final reports. Offer QA leadership and expert guidance to project teams on qualification, validation, and CSV topics across ongoing CAPEX initiatives. Ensure appropriate qualification of vendors and assessment of supplier‑provided documentation. Serve as the primary Quality point of contact within GQE for all matters relating to equipment, infrastructure, and computerized‑system lifecycle management and compliance. Ensure proper documentation and traceability within global quality systems (e.g., Kneat, TrackWise, DMS, Unifier). Manage Quality deviations, change controls, and CAPAs/tasks, ensuring timely resolution and escalation where appropriate. Requirements Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related scientific/technical discipline. Significant experience working within a GMP‑regulated pharmaceutical environment, ideally within a Quality Unit. Demonstrated experience in a QA role focused on CSV and automation for GMP systems, particularly those supporting aseptic fill‑finish operations (e.g., filling equipment, lyophilizers, clean utilities, cleanroom facilities). Strong understanding of qualification/validation requirements for equipment and computerized systems within a pharmaceutical manufacturing setting. Ability to influence project teams and provide clear, authoritative QA direction in a dynamic environment. Excellent communication skills in English; German language skills are an advantage. Seniority level Mid‑Senior level Employment type Contract Job function Quality Assurance Industries Biotechnology Research and Pharmaceutical Manufacturing #J-18808-Ljbffr
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QA Specialist, CSV Automation
Vor 5 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 5 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 Specialist, CSV
Vor 5 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 6 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 5 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 - CQV/CSV Specialist
Vor 7 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, CSV
Vor 5 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
vor 21 Stunden
Stein, Schweiz CTC Resourcing Solutions VollzeitQA Specialist, CSV & Automation – 6785 ASH 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 QA Specialist, CSV & Automation for a one year contract role based in the Stein Switzerland. The QA Specialist, CSV & Automation is...
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QA Specialist
Vor 5 Tagen
Stein, Schweiz Proclinical 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 21 Stunden
Stein, Schweiz Coopers Group AG VollzeitA leading pharmaceutical company in Switzerland is seeking a QA Specialist, CSV & Automation for a contract role. This position plays a critical part in ensuring quality and compliance in aseptic drug product manufacturing. Responsibilities include overseeing qualification and validation compliance, providing QA support for major projects, and ensuring...
