QA CSV Specialist

QA CSV Specialist

For our Client in Visp we are searching for a Computer System Validation Specialist/Engineer (CSV) to carry out a variety of tasks related to the validation and lifecycle management of computerized systems

Key Responsibilities:

• Identify or create industry best practices and implement these within the framework of existing GAMP regulations. 

• Strategic implementation of CSV process improvements and tactical support of CSV operations to meet the changing needs of the business. 

• Continually monitor industry regulation and trends and apply this knowledge to optimize clients policies and procedures.

• Carry-out 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 guidance 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

• Ensure the department is operating as efficiently as possible by eliminating activities that do not positively impact production capacity or compliance. 

• Develop a project scope, implementation plan and tracking mechanisms, while being forward looking to identify roadblocks and solutions prior to issues affecting the project schedule.

• 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.

Qualifications:

• Education Required: Bachelors degree in Engineering, Information Technologies, Natural Sciences or related

• Advanced Level Pharma Industry minimum 5 years experience.

• Experience and in-depth understanding of all system lifecycle deliverables from Commissioning & Qualification (C&Q) and Computer System Validation (CSV) documentation

• Knowledge of applicable regulatory requirements (GMP Annex 11, 21CFR, GAMP, PICS...).

• Language: English required, German advantage