Validation Lead

Hobson Prior are looking for a Validation Lead to support all site functions with regards to facility, equipment, process, analytical method and computerised systems validation activities. You will have the opportunity to join an innovative clinical-stage immunotherapy organisation.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Leading compliance with Validation Master Plan and QMS policies and standard operating procedures (SOPs).
• To be producing validation plans, protocols and reports.
• Project managing and executing validation exercises.
• Supporting QMS processes and taking part as required in supplier qualifications, deviation investigations, CAPA and change control implementations.
• To be supervising equipment maintenance and calibration schedules.
• You will be organising validation and technology transfer activities with sister sites, suppliers and third parties.
• To be liaising with Production, Quality Control, Quality Assurance, Regulatory Affairs and Supply Chain providing as necessary to support compliance with GMP and regulatory requirements.
• Supporting Quality Assurance team with general QA activities where required.
• To be deliver training to site personnel.
• You will execute risk assessments and impact assessments.
• Confirming compliance and qualification of systems with respect to Data Integrity guidelines.

Key Skills:

• Good interpersonal, verbal and written communication skills.

Requirements:

• Bachelor's degree in the biological/pharmaceutical sciences or pharmaceutical/biological process engineering discipline.
• At least 5 years GMP experience in validation related roles within a biotech, sterile products or biologics manufacturing environment.
• Experience spanning facility, equipment, process, analytical method and computerized system validation.
• Experience of implementing and qualifying data integrity controls form computerized systems and equipment.
• Knowledge of Quality Management System elements and experience in maintaining and improving systems supporting the QMS.
• Working knowledge and ability to apply GMPs in conformance with FDA, MHRA, EU, ISPE, ISO, GAMP and ICH standards.
• Experience with application of risk management practises and problem-solving techniques e.g. conducting risk assessments, impact assessments, FMEAs etc.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.