Job Description

The Life Science Career Network - CTC are specialised industry experts who can help companies source the best talent and provide reliable HR and consulting services, support varied candidates in finding promising career opportunities and offer the latest in skill development training programmes.
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 Validation Specialist for a contract role of 12 months to be based in the Valais area, Switzerland.
QA Validation Specialist
QA Validation Specialist is responsible for supporting efforts that ensure all critical GMP regarding equipment, facility and/or systems are validated and maintained in compliance with user requirements, process parameters and global regulatory guidelines. The specialist works closely with Operations, Quality Assurance, clientele, and regulatory bodies with scientifically sound, documented evidence that the systems and processes will perform as required so they can be assured of a quality, compliant manufacturing environment. At this level the specialist must possess a full grasp of the duties of Qualifications and Validation and is a resource to less experienced members
Main Responsibilities:
Perform QA oversight of the Validation review and qualification activities to ensure GMP equipment, facility and/or systems are continuously maintained in a validated/qualified state
Schedule own tasks to be performed as well as tasks for Level 1 as determined by the Validation Manager
Perform change control assessments for GMP equipment, facility and/or systems and associated validation activities to ensure compliance with regulatory requirements
Demonstrate a thorough understanding of Cell and Gene manufacturing equipment, facility and/or system and validation procedures for Installation Qualification (IQ), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms and Equipment
Develop validation protocols from Validation plans (if applicable)
Provide strong technical expertise when reviewing and approving SOPs, protocols, reports, change controls, deviations and other records
Perform assigned Quality Systems activities including Document Management System (DMS), Laboratory Information Management System (LIMS), Validation and Qualification Management System (Kneat) and Trackwise system (Change Control, Deviations, CAPA, etc.)
Perform other duties as assigned
Qualifications and Experience:
Relevant working/residency permit or Swiss/EU-Citizenship required
Bachelor's degree in Science or Technical
3+ years of experience in QA Validation of equipment, facility and/or systems within Pharma
Experience with oversight of aseptic processing and the associated international aseptic processing regulations
Excellent written and oral communication to include accurate and legible documentation skills; ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic
Ability to interface and communicate directly with clients is required
Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects
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