Talentmark are recruiting for a Quality Validation Specialist, to join a well-established and successful global pharmaceutical company, based in Hatfield, Hertfordshire, for a 12 month fixed term contract.
Role:
You will be responsible for providing Quality oversight, validation expertise and strategic support for the successful delivery of expansion projects. You will ensure that all qualification and validation activities associated with new facilities, utilities, warehouse operations, and packaging lines are planned and executed in accordance with company procedures, regulatory expectations, and industry standards.
Key duties will be to:
Support the development and implementation of qualification and validation strategies for the company facility expansion project, including the new cold‑chain warehouse, packaging lines, facility extensions and utility modifications.
Support the generation, review and approval of project validation documentation including Qualification Plan, URS, Design Qualification, Risk Assessments, FAT/SAT protocols, commissioning documentation, IQ/OQ/PQ protocols, validation reports and traceability matrices in line with company procedures and regulatory expectations.
Provide Quality oversight to ensure commissioning and qualification activities are executed in compliance with GMP, GDP, Annex 15, GAMP 5 and company requirements.
Coordinate with Engineering, Production, QC, Supply Chain and other stakeholders to ensure equipment, systems and facilities are introduced, qualified and handed over in a controlled and compliant manner in accordance with the company's change management procedures.
Support and review validation activities for facility and utility systems such as HVAC, compressed air, environmental monitoring systems and temperature‑controlled storage areas.
Provide Quality input to project design reviews, equipment selection, process flow development and risk assessments ensuring validation requirements are incorporated from early project stages.
Participate in investigations for deviations or non‑conformances arising during commissioning and qualification, ensuring appropriate root cause analysis, corrective actions and preventive actions are defined.
Prepare and update SOPs and training materials associated with qualification, validation and project delivery processes as required.
Support project teams with regulatory compliance guidance, ensuring project documentation is inspection‑ready and aligned with cGxP expectations.
Identify and implement continuous improvement opportunities to enhance qualification and validation processes, project delivery efficiency and compliance.
Provide training and coaching to project personnel and internal stakeholders on qualification, validation and Data Integrity requirements.
Act as a strong advocate of Data Integrity, ensuring documentation, testing and record management associated with the projects comply with ALCOA++ principles.
Perform any appropriate duties at the request of the Quality Validation Manager.Your Background:
Educated to degree level or above in a scientific or related field with significant experience in a pharmaceutical industry role focused on Electronic Quality Systems.
Proficient knowledge of electronic systems, CSV and GAMP requirements and the ability to understand and analyse user requirements to facilitate changes and system improvements.
Working knowledge of facility and utility systems such as HVAC, compressed air, environmental monitoring systems
Good understanding of the requirements of data integrity and application to system management.
Good understanding of Quality Control Systems and analytical software and electronic Quality Systems.
Good understanding of GMP Guidelines and Regulations.
Knowledge of the qualification and validation requirements for equipment and electronic systems.
Excellent verbal and written communication skills.Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference (Apply online only) in all correspondence