QA Validation Specialist (6564)

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

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.