QA CSV Specialist

Main Responsibilities

• Represents the QA department and act as a liaison between QA CSV and its internal and external customers
• Continually monitors industry regulation and trends and applies this knowledge to optimize clients policies and procedures for completing a variety of tasks relating to the validation and lifecycle
• Management of computerized systems including process control systems (MES, Delta V), spreadsheets and bench‑top equipment
• Provide expert technical IT guidance to the Manager for GMP decisions regarding the validation and lifecycle management of computerized systems
• Responsible for implementing continuous improvements, procedures and local Validation Plans and Master Plans to ensure the department is operating as efficiently as possible by eliminating activities that do not positively impact production capacity or compliance
• Capable of quickly developing a project scope, implementation plan and tracking mechanisms, while being forward looking to identify roadblocks and solutions prior to issues affecting the project
• Actively audit projects and systems to ensure that the appropriate validation activities are carried out and are in compliance with regulatory requirements & corporate standards
• In conjunction with engineering, automation, operations and other departments, evaluate new applications in order to identify validation requirements
• Act on behalf of, or be a conduit to, the QA CSV Manager on CSV issues to ensure that GMP issues are identified and addressed timely and correctly

• Relevant working / residency permit or Swiss / EU-Citizenship required
• Bachelor’s degree in Engineering, Information Technologies, Natural Sciences or related.
• 5-10 years of CSV experience in Pharma industry
• Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documents through System Retirement, as well as the regulatory requirements applicable (GMP Annex 11, 21
  
  CFR, GAMP, PICS…)
• English is mandatory and German is nice to have
• Hybrid possibility – 2 days home office