QA Validation

Role will report to the Head of QA Validation & Qualifications. The core team this role will sit in includes 2 permanent hires and this fixed-term contract position. The specialist works closely with Operations, Engineering, our clientele, and regulatory bodies 

The QA Validation Specialist is responsible for ensuring that GMP equipment, facilities, and systems are properly qualified, validated, maintained in a compliant state, and supported through change control, documentation review, audits, and regulatory inspections to guarantee product quality and patient safety.

Project Monarch refers to a major expansion of mammalian cell culture and biologics manufacturing capabilities located at the company's site in Visp, Switzerland. The large-scale project is integrated within BioAtrium, and involves advanced automation, complex process control, and large-scale manufacturing operations. 

• Key responsibilities 
• 
  
• Must possess a full grasp of the duties of Qualifications (CQV) and Validation.
• 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, like participate to Audits and inspections to demonstrate the compliance of the facility, equipment and systems with both European and US (FDA) regulations, and continuous improvement initiatives.

Essential Requirements

• GMP-regulated pharmaceutical, biotech, or cell & gene therapy environment.
• 2–6 years Validation / Qualification Experience
• The candidate should understand:
  • IQ (Installation Qualification)
  • OQ (Operational Qualification)
  • PQ (Performance Qualification)
  • Validation lifecycle
  • Maintaining systems in a validated state.
  • Change Control Experience
  • Documentation Review Experience
• Must have experience reviewing and approving:
  • SOPs 
  • Validation protocols 
  • Validation reports 
  • Deviations 
  • CAPAs 
  • Change controls
• Familiar with EU GMP and FDA regulations
• English Proficiency (German a strong plus)
• Academic background not essential provided candidate has the right working experience , but ideally with a Science or Technical Degree in Engineering, Biotechnology, Chemistry, Biology, Pharmacy, or related field. 

Personal attributes:

Looking for someone to be able to hit the ground running in a critical stage of the project, some able to pick things up rapidly, work autonomy and within a fast-paced environment. An Individual who will work comfortably in a multicultural set up in a highly collaborative team environment. 

The role holder will join a critical phase of an impactful project, and join a highly collaborative team with a mindset of working as one Team, This would be a great opportunity to make an impact and provide unique networking opportunity in a growing and dynamically growing business.