QA CSV Specialist

Main responsibilities:

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

Your experience:

• Bachelors degree in Engineering, Information Technologies, Natural Sciences or related.
• Fluent in English required, German is an advantage.
• Minimum 5 years experience in the 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, 21CFR, GAMP, PICS...).