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Qualification-Validation Expert

ROLE OVERVIEW

An exciting opportunity for a Quality & Validation Specialist to join a leading pharmaceutical organization supporting the transition of a building from project to routine operations. This strategic role is based remotely with limited field activities, primarily focusing on stabilizing and managing the building’s quality systems, processes, and data integrity within a complex transitional environment. The successful candidate will play a critical part in ensuring a controlled, compliant, and efficient transition through detailed analysis, process improvement, and stakeholder collaboration.

This role offers a unique chance to apply your expertise in qualification, validation, and quality systems to influence a key operational phase, supporting the ongoing success of our client's site.

KEY DUTIES AND RESPONSIBILITIES

Your duties as the Quality & Validation Specialist will be varied however the key duties and responsibilities are as follows:
  • Provide a comprehensive analysis of current state procedures, tools, and data, identifying gaps and areas for improvement to ensure a smooth transition into routine operations.
  • Determine which activities, data, and practices are necessary for ongoing compliance, justifying decisions with documented risk assessments and quality rationale.
  • Develop and implement governance and monitoring tools for workload, projects, and routine activities to provide clarity and control.
  • Manage the project-to-routine transition process, aligning equipment data, identifying gaps, and creating deviations as needed.
  • As the Quality & Validation Specialist, you will support documentation updates and present proposals to management and quality stakeholders for approval and joint validation.

ROLE REQUIREMENTS

To be successful in your application to this exciting role as the Quality & Validation Specialist we are looking to identify the following on your profile and past history:
  • A Degree or higher level in a scientific or quality-related field (e.g., Pharmaceutical Chemistry / Quality Assurance / Quality Management).
  • Proven experience in Qualification & Validation within a regulated environment, with a strong understanding of quality systems and compliance requirements.
  • Ability to analyze complex, imperfect situations, structure processes pragmatically, and justify decisions to Quality stakeholders.

Key Words: Quality / Validation / Systems / Process / Compliance / Transition / Risk / Stakeholders / Data / Documentation / Control / CQV / Qualification / QA

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career".

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.

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