Job Title: Quality Assurance (QA) Validation Specialist
Location: Yorkshire/Humber
Contract: Permanent, Full Time
Work Hours: 37.5
Randstad Sourceright, a leading provider of RPO & MSP Recruitment Services are currently recruiting for a Quality Assurance (QA) Validation Specialist on behalf of a global CDMO organization.
Role Purpose:
In this role you will have the QA oversight and control of site Validation activities to ensure compliance and cover a broad spectrum of validation disciplines, including but not limited to:
* Process Validation / CPV
* Facility and Equipment Validation/Qualification
* Cleaning Validation
* Storage Area Validation
* Analytical Method Validation
* You will ensure validation processes, procedures and execution are in compliance with GMP requirements.
Key Accountabilities:
* Own the Site Validation Master Plan
* Implementation and oversight of robust Validation Lifecycle based procedures and business processes with key stakeholders
* Review and approval of Validation protocols and reports
* QA lead SME for Validation related topics within Audits and Inspections
* QA SME for GMP engineering qualification projects, ensuring compliance to site and corporate procedures
* Design and conduct training and education
* Oversight of periodic verifications and reports (Equipment, process, temperature mapping etc.)
* QA Support and input to applicable deviations and change controls
* Collaborate with key stakeholders to deliver robust business processes and improvements
* Monitoring and oversight of critical clean utilities from quality perspective (e.g. Purified Water, Nitrogen, Cleanrooms etc.)
* Work closely with site eCompliance Lead supporting Computer System Validation
* Ensure data generated/supporting validation is in compliance with ALCOA+ principles throughout its lifecycle
Key Requirements:
* Technical experience within GMP / Pharmaceutical environment, including managing projects and validation activities.
* Broad knowledge of Validation concepts and Lifecycle verification.
* Focus on high quality; good at planning, organizing and communication.
* Empowerment, motivating others and development direction.
* Understands how to effectively engage others within project/change processes.
* Champion and role model the values of diversity and inclusion through everyday interactions.
* Ensure clear and direct 2-way communication within their team and other organizations.
* Able to work cross-functionally, indirectly influencing key stakeholders.
* Proactive, take responsibility within their area of the business.
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