Negotiable
Outside
Undetermined
Harlow, England, United Kingdom
Summary: The role of PasX Consultant involves acting as a Product Owner for a 6-month contract, focusing on bridging communication between business stakeholders and development teams. The consultant will ensure project requirements are met in alignment with business goals while collaborating closely with the Tech Product Manager and Test Lead. This position requires expertise in clinical and manufacturing processes, particularly in a regulated environment. The consultant will also oversee documentation and testing to ensure compliance and functionality.
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.
Key Skills:
- 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.
- 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.
Salary (Rate): undetermined
City: Harlow
Country: United Kingdom
Working Arrangements: undetermined
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other