Aktuelle Jobs im Zusammenhang mit Process Quality Assurance Specialist - Basel, Basel-Stadt - CTC Resourcing Solutions AG
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Quality Assurance Manager
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Quality Assurance Manager
vor 4 Wochen
Basel, Basel-Stadt, Schweiz Gi Group SA VollzeitFor our client's company in Basel, we are looking for aQuality Assurance Manager- You review and approve SOP's, protocols, reports, Certificate of Analysis and other quality-related documents- You have a high sense of detail orientation and support investigations of deviations and out of specifications (OOS)- You maintain, record and process corrective and...
Process Quality Assurance Specialist
vor 1 Woche
We are seeking a highly skilled CQV Engineer to join our team in the Stein area, Switzerland. The successful candidate will be responsible for executing and coordinating defined CQ activities in the High Bay GMP Warehouse for both cold and ambient temperatures.
Main Responsibilities:- Ensure that CQV activities are executed in accordance with CORP 35, the C&Q Plan and supporting Validation Plans.
- C&Q SME for High Bay warehouse scope - cold and ambient (high preference).
- Support C&Q execution for key main equipment: Semi-automated and fully automated visual inspection machine, other small support equipment in Building 413 (LAF, thawing units, fridges, freezers, cold/freezer rooms, etc.), including alignment with execution approach of equivalent systems in QC building.
- Execution of the commissioning activities related to allocated areas or systems.
- Coordination of execution activities with supporting CSV Team and global IT teams.
- Lead C&Q testing activities supported by vendors and contractors.
- Develop any supporting validation plans related to scope of execution.
- Support the updates of Master C&Q Plan and supporting plans during project execution lifecycle.
- Interface with other disciplines: HSE, Automation, Electrical, Instrumentation, Operation and Engineering, etc.
- Assist the C&Q Lead with the Handover and Release process.
Key Qualifications and Experience:
- Relevant working/residency permit or Swiss/EU-Citizenship required.
- Experience in use of Kneat for documentation development and execution.
- A relevant Third Level or Professional Qualification.
- Ability to work well under pressure and within strict deadlines.
- Minimum of 8 Years extensive experience in areas/systems under future responsibility.
- Preferably Diploma level degree in Mechanical or Chemical Engineering.
- Previous experience in authoring CQV lifecycle documents necessary.
- Previous experience in qualifying a High Bay warehouse (ambient and 2 to 8 degree cold room) necessary.
- Proactive and able to work independently.
- Considerable experience with cGMP.
- Strong interpersonal and communication skills.
- Fluent English (C1 Level), German an advantage.