QA Validation Specialist

Randstad Enterprise; Kingston upon Hull; On-site; GBP 35,000 - 50,000; Full time

Job summary

Randstad Enterprise is seeking a Quality Assurance (QA) Validation Specialist to ensure compliance and oversight of key validation activities within a global CDMO organization. The role involves managing validation processes across various disciplines such as process, facility, and cleaning validation, and requires technical experience in a GMP environment. Ideal candidates will possess strong project management skills and the ability to communicate effectively with key stakeholders, contributing to robust business processes.

Qualifications

• Technical experience within GMP / Pharmaceutical environment, including managing projects and validation activities.
• Ability to engage effectively within project/change processes.
• Proactive and responsible attitude within their area of the business.

Responsibilities

• Oversee validation activities ensuring compliance to GMP standards.
• Implement robust validation lifecycle procedures.
• Collaborate with stakeholders to improve business processes.

Skills

Project Management

Validation Concepts

Communication

Planning

Organizing

Process Improvement

Job description

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.