Job Description
We are looking for an experienced PasX Consultant to act as a Product Owner for a 6-month contract, with the possibility of extension. The consultant will serve as the key point of contact for business stakeholders and development teams, ensuring the effective delivery of project requirements in alignment with business goals. This role will require close collaboration with the Tech Product Manager and Test Lead to deliver the project roadmap and meet stakeholder expectations.
Key Responsibilities:
* Act as the primary liaison between business stakeholders and development teams, gathering and translating business requirements into actionable user stories.
* Explain detailed business requirements to the development team, ensuring a clear understanding of objectives and deliverables.
* Oversee and contribute to the writing, reviewing, and approval of technical and validation documents to ensure GxP compliance.
* Conduct both informal and formal test executions to verify system functionality against business requirements.
* Work closely with the Tech Product Manager to maintain alignment with the project roadmap.
* Collaborate with the Test Lead to support test planning and execution.
Required Experience & Knowledge:
* Deep knowledge of clinical and manufacturing processes, particularly within a regulated (GxP) environment.
* Proven experience with Manufacturing Execution Systems (MES) and electronic Batch Records (eBR), preferably within the pharmaceutical or life sciences industry.
* Strong understanding and experience with GxP validation documentation processes.
* Familiarity with Agile ways of working (Agile WoW) and project management within Agile environments.
Soft Skills:
* Excellent communication skills to interact effectively with both technical and business stakeholders.
* Strong organizational skills with the ability to prioritize tasks effectively.
* Detail-oriented with a focus on quality and compliance.
* Proactive problem-solving skills and the ability to work independently with minimal supervision.