About the Role
The successful candidate will work closely with quality, operations, technical, facilities and administrative teams to coordinate validation schedules, maintain controlled documentation, monitor testing activities and ensure required records are completed accurately and within agreed timelines.
This role is suitable for someone with experience in validation, quality assurance, compliance, technical administration, document control or regulated operations who is comfortable working with structured procedures, technical information and multiple stakeholders.
Key Responsibilities
Validation Coordination: Coordinate planned validation, qualification and verification activities across assigned operational areas.
Validation Planning: Maintain schedules for validation, revalidation and related quality activities.
Protocol Administration: Support preparation, review, circulation and completion of approved validation protocols.
Validation Documentation: Maintain accurate and complete documentation for assigned validation activities.
Testing Coordination: Arrange testing and verification activities with relevant technical and operational teams.
Qualification Support: Assist with qualification activities for equipment, systems and operational processes.
Installation Verification: Support documentation confirming that equipment or systems have been installed according to approved requirements.
Operational Verification: Coordinate checks confirming that equipment and systems operate as intended.
Performance Verification: Support testing designed to demonstrate consistent performance under expected operating conditions.
Acceptance Criteria: Ensure required testing criteria are clearly documented before validation activity begins.
Test Results: Record and organise validation and verification results accurately.
Validation Reports: Assist with preparation of validation completion reports and summaries.
Revalidation Tracking: Maintain records showing when equipment, systems or processes require repeat validation.
Validation Status: Maintain accurate information showing completed, planned, overdue and outstanding activities.
Equipment Records: Maintain qualification and validation records relating to operational equipment.
System Records: Support maintenance of validation information for relevant systems.
Process Validation: Coordinate supporting documentation for processes requiring formal validation.
Deviation Recording: Document deviations identified during validation or testing activities.
Deviation Tracking: Monitor validation-related deviations through investigation and closure.
Corrective Actions: Maintain records relating to corrective actions arising from validation findings.
Preventive Actions: Support tracking of actions designed to prevent recurring validation issues.
CAPA Support: Assist with documentation and follow-up of corrective and preventive action plans.
Change Control: Support validation documentation when equipment, systems or processes are modified.
Impact Assessment Support: Gather information required to understand how proposed changes may affect validated activities.
Document Review: Review validation documentation for completeness, consistency and required approvals.
Approval Tracking: Monitor validation documents awaiting review, signature or final approval.
Version Control: Ensure controlled validation documents are clearly identified and current.
Document Control: Maintain organised electronic and physical validation records.
Record Retention: Store validation documentation according to established retention procedures.
Data Integrity: Ensure validation records remain complete, accurate, consistent and traceable.
Data Entry: Enter validation status, test information and completion details into relevant systems.
Quality Systems: Maintain validation information within quality-management systems.
Calibration Coordination: Monitor calibration information where equipment calibration affects validation status.
Maintenance Coordination: Work with maintenance teams where servicing or repairs require additional validation review.
Supplier Documentation: Request and organise technical or validation information from suppliers.
Contractor Coordination: Liaise with approved external providers involved in testing or qualification activities.
Operations Coordination: Schedule validation activities with operational teams to minimise disruption.
Quality Team Support: Provide validation records and status information required for quality reviews.
Facilities Coordination: Support qualification activities involving facilities, utilities or controlled environments where applicable.
Compliance Checks: Review completed records against established validation procedures.
Audit Preparation: Organise validation documentation before internal or external reviews.
Audit Support: Retrieve protocols, reports and supporting evidence during audits.
Audit Findings: Support follow-up of actions relating to validation observations.
Validation Meetings: Coordinate routine validation review meetings where required.
Meeting Documentation: Prepare agendas, progress information and supporting records.
Action Tracking: Maintain trackers for outstanding validation actions and responsibilities.
Schedule Monitoring: Highlight upcoming deadlines and activities at risk of delay.
KPI Reporting: Support monitoring of completion rates, overdue activities and validation performance indicators.
Status Reporting: Prepare regular validation updates for quality and operational stakeholders.
Procedure Updates: Support approved updates to validation procedures and supporting templates.
Training Records: Maintain records showing required procedural training has been completed where applicable.
Issue Escalation: Escalate significant validation discrepancies to the appropriate quality or technical representative.
Cross-Functional Communication: Maintain clear communication across quality, technical, facilities and operational teams.
Continuous Improvement: Identify opportunities to improve validation scheduling, documentation and follow-up processes.
What We Are Looking For
Experience: Previous experience in validation, quality assurance, technical administration, compliance, document control or a comparable regulated environment.
Validation Knowledge: Understanding of structured validation, qualification or verification activities.
Quality Awareness: Good understanding of quality-management principles and controlled processes.
Documentation Skills: Strong ability to maintain accurate technical and compliance records.
Attention to Detail: High level of accuracy when reviewing protocols, results and supporting information.
Analytical Skills: Ability to review validation information and identify discrepancies or incomplete actions.
Planning Skills: Strong ability to coordinate multiple activities against agreed timelines.
Schedule Management: Confidence maintaining trackers and following up outstanding validation tasks.
Data Accuracy: Careful approach to maintaining testing, status and completion information.
Microsoft Excel: Good spreadsheet skills for tracking, analysis and reporting.
Microsoft Word: Comfortable preparing structured reports and controlled documentation.
Quality Systems: Experience with electronic quality-management or document-control systems would be advantageous.
Technical Awareness: Comfortable working with equipment, systems and operational-process documentation.
Change Control Awareness: Familiarity with controlled change processes would be beneficial.
CAPA Awareness: Understanding of corrective and preventive action processes would be advantageous.
Problem Solving: Methodical approach to deviations, incomplete testing and documentation issues.
Communication: Clear and professional written and verbal communication skills.
Stakeholder Coordination: Ability to work effectively with quality, technical, operations and facilities teams.
Prioritisation: Ability to manage planned activities alongside urgent compliance requirements.
Compliance Focus: Strong appreciation of the importance of approved procedures and traceable records.
Reliability: Consistent approach to deadlines, documentation and follow-up responsibilities.
Adaptability: Comfortable adjusting schedules when technical or operational priorities change.
Preferred Background
Quality Environment Experience: Previous experience within a structured quality-controlled or regulated operational environment would be beneficial.
Validation Exposure: Hands-on experience supporting equipment, system or process validation is preferred.
Document Control Experience: Familiarity with controlled-document review, approval and version-management processes would be useful.
Audit Exposure: Experience preparing documentation for internal or external audits would be advantageous.
Technical Administration: Background supporting engineering, facilities, manufacturing or operational teams would be beneficial.
Quality Management Systems: Familiarity with electronic QMS platforms or validation-management systems is desirable.
Process Improvement: Experience identifying improvements to administrative or compliance workflows would be valuable.
Formal Qualification: A qualification in quality, science, engineering, business operations or a related discipline would be helpful but is not essential where relevant experience can be demonstrated.
Role Priorities
Success in this role will depend on maintaining accurate, complete and traceable validation records while ensuring planned activities are completed within agreed schedules.
The role requires someone who can confidently coordinate multiple technical and administrative activities at the same time, communicate clearly with different departments and identify potential delays before they affect completion dates.
Strong performance will also involve keeping documentation review, approvals, deviations and corrective actions moving efficiently through each stage while maintaining reliable records that can support quality reviews and audits.
Pay: £38,000.00-£40,000.00 per year
Work Location: In person
