[ref. e70989000] Validation Specialist (Quality Assurance)
The position
Joining our company, you will gather an overview of the GBS Enabling Services Organization with a particular focus on the tasks and responsibilities from Validation Management. You will work in a globally operating team that designs, builds and continuously improves Boehringer Ingelheim’s global Processes, using agile principles, methods and tools on a daily basis.
You will be qualified to contribute to a cross-functional team, and as a Validation Specialist in the area of Quality Assurance you will be able to coordinate the activities around change requests, performing impact analysis, reviewing, and approving documents and ensuring a validated state of the system.
Tasks & responsibilities- Based on your expertise in Computer System Validation, you ensure that changes are managed according to our validation rules in close cooperation with local experts in our GBS user community.
- Acting as a Validation Management Specialist, you support our daily operation of processes and applications.
- Ensure that our processes and systems are always compliant and in a validated state.
- Furthermore, you manage the execution and documentation of testing activities.
- You are familiar with Agile methods and tools, participating to projects driven with this methodology.
- You are familiar with working in projects and being measured against Key Performance Indicators (KPIs) / Service Level Agreements (SLAs) to strive for continuous improvement measures.
About our future employee
You should speak English fluently and have experience in validation management, preferably in the CSV area.
Additionally, we are looking for:
- Bachelor’s Degree; preferably in engineering, sciences, pharmaceuticals or biotechnology or equivalent and longstanding professional experience in regulations and processes.
- Ideally profound knowledge and understanding of Computer Systems Validation regulation (CSV), including GAMP5, 21 CFR Part 11, CSA framework and EU Annex 11, and Data Integrity regulation.
- Experience in one or more of the following domains required:
- Experience in SAP, MES, LIMS, databases, interfaces, and/or related experience (In Process Controls or Quality Control)
- Experience in ALM tools or Structured authoring tools (Polarion, Azure Dev Ops, Docuvera), and related pharma experience (Equipment Qualification and Software Validation)
- Experience in electronic Quality Management Systems (Track Wise, Veeva) and/or related pharma experience (Quality Management).
- Good Knowledge of Gx P (Good Practices) regulations within the Pharmaceutical Industry.
- Experience with agile methods (e.g., SCRUM, Kanban) and tools (e.g., JIRA) would be an advantage.
- Good analytical capabilities and problem-solving competence including a proper understanding of prioritization.
- Dedicated team player with good communication skills, and a structured way of working.