QA Specialist, CSV
vor 15 Stunden
QA 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 responsible for the qualification and validation compliance of equipment and computerized systems related to aseptic facilities, equipment and utilities related to the GMP manufacturing of drug products. Responsibilities Responsible for the compliance of commissioning and qualification of large CAPEX projects (e.g. new drug product facility) from ideation to execution phases, throughout all design phases. Ensures that qualification/validation plan and execution of equipment, infrastructure and computerized‑systems are in place. Approves SOPs, commissioning/qualification/validation protocols and reports as well as project related CQV / CSV documents (e.g. URS, FAT/SAT, etc.). Provides QA leadership, oversight and support to staff on qualification/validation topics related to ongoing projects and ensures that selected vendors are qualified. Acts as first point of contact within GQE for any area related to the lifecycle and compliance for equipment, infrastructure and computerized‑systems qualification/validation, including documentation in shared global systems (e.g. Kneat, Trackwise, DMS, Unifier, etc.). Manages Quality deviations, changes and CAPAs/tasks in an open and timely manner, taking leadership for their resolution, but escalating when necessary. Qualifications and Experience Relevant working/residency permit or Swiss/EU-Citizenship required. Bachelor or Master’s degree in Engineering, Life Sciences or related field. Significant experience in the GMP regulated pharmaceutical industry, preferably in a role within a Quality Unit. Experience in a QA role for the CSV / Automation of GMP systems related to aseptic fill‑finish processes and facility (filling equipment, lyophilization, clean utilities, and clean room facilities). Fluent in English; German would be an advantage. Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone. Additional Information Seniority level: Mid‑Senior level Employment type: Contract Job function: Information Technology Industries: Pharmaceutical Manufacturing and Biotechnology Research #J-18808-Ljbffr
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QA Specialist, CSV
vor 15 Stunden
Stein, Schweiz Coopers Group AG VollzeitContract 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...
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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 4 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 4 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
Vor 4 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 15 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...
