QA Validation Specialist 100 %

In this role , you will support the validation and qualification of GMP-critical equipment, facilities, and systems to ensure compliance with regulatory standards. You will collaborate with cross-functional teams to maintain validated states, review validation documents, and assess change controls. Your expertise will help uphold a high-quality, compliant manufacturing environment in the cell and gene therapy space.

Start Date : 01/09/2025

Duration : 12 Months

Place of Work : Visp

Key Responsibilities

• Support validation activities for GMP equipment, facilities, and systems, ensuring ongoing compliance and validation status
• Review qualification protocols, reports, and validation documents, providing technical guidance and approval
• Perform change control assessments related to GMP systems and equipment, verifying regulatory adherence
• Develop validation protocols based on validation plans, ensuring clear and effective documentation
• Oversee validation review processes to confirm systems remain in a validated state throughout their lifecycle
• Manage documentation within systems such as DMS, LIMS, Kneat, and Trackwise, ensuring accuracy and traceability
• Contribute to the review and approval of SOPs, deviations, CAPAs, and other quality records
• Schedule and prioritize tasks independently, supporting validation and qualification activities
• Demonstrate a solid understanding of cell and gene therapy manufacturing equipment and validation procedures, including IQ, autoclaves, clean utilities, temperature mapping, and controlled storage validation
• Perform additional duties related to quality systems and validation activities as needed

Candidate Profile

• Bachelor’s degree in science, engineering, or a related technical field
• Minimum of 2 years of experience within the pharmaceutical or biotech industry, ideally in validation or quality assurance roles
• Strong knowledge of validation processes for GMP-critical equipment and systems
• Familiarity with qualification protocols such as IQ, OQ, PQ, and validation of utilities and storage environments
• Experience with validation systems like Kneat, Trackwise, DMS, or LIMS is advantageous
• Excellent attention to detail, organizational skills, and the ability to prioritize tasks independently
• Good communication skills and the ability to collaborate effectively with cross-functional teams

Job ID

#J-18808-Ljbffr