Senior Quality Assurance Process Specialist
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 Demand to Deploy. 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 P2Q Senior Process Specialist in the area of Quality Assurance, you will be able to coordinate and propose solutions within the Demand Management process, as well as actively take part of Change and Release Management for P2Q.
Tasks & responsibilities
• Based on your expertise in Quality Assurance 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 P2Q Senior Process Specialist, you support our daily operation of processes and applications.
• You ensure that our processes and systems are always compliant and in a validated state.
• Furthermore, you manage the execution and documentation of testing activities.
• As part of cross-functional teams, you ensure the implementation and continuous improvement of our standardized processes in global projects.
• Based on strong communication skills, you manage stakeholder interactions successfully and define the level of standardization for our processes and / or systems.
• You will be responsible for below listed tasks in Release Management area:
- Change request management in TrackWise
- Updates of SLC documentation
- Testing in HPALM
- Training material updates
• 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
We are looking for experience in one or more of the following domains:
• SAP, MES, LIMS, databases, interfaces, and/or related experience (In Process Controls or Quality Control).
• ALM tools or structured authoring tools (Polarion, AzureDevOps, Docuvera), and related pharma experience (Equipment Qualification and Software Validation).
• Electronic Quality Management Systems (TrackWise, Veeva) and/or related pharma experience (Quality Management).
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.
• Good Knowledge of GxP (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.
• Excellent business English