As Validation Specialist, your role is to coordinate the validation activities for structural equipment and process in the Belgium Quality Control building.
You act also as the Single Point of Contact (SPOC) and / or Subject Matter Expert (SME) for validation topics like cleaning, autoclaves, utilities, controlled room, for QC.
Key responsibilities :
Through the validation team, you deliver validation services including process control validation for laboratory equipment (writing and reviewing / approval of protocols, execution, management of change control, deviations & CAPAs)
You are responsible for the coordination of the process validation of analytical systems and / or structural equipment (control / monitor planning)
You are responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards.
You act as SME (Subject Matter Expert)
You are responsible for ensuring inspection readiness regarding validation during internal GSK audits and external authorities inspections and to ensure follow-up of commitments.
You are fronter during audits and inspections
You ensure compliance with QA within its scope of responsibility.
You ensure the compliance on EHS topics in / outside his / her area and develop the EHS mindset
You manage and develop a team of 5 people including technicians, coordinators & consultants / contractorsµ
Basic Qualifications :
University (Master) degree in Science / Biological Engineering (e.g. Pharmacist / master’s in sciences / Bio Engineer or Graduate with at least 7 years of experience
You have knowledge of International standards (CFR and Eudralex), GMP and Regulatory
You have at least 3 years’ experience in validation, aseptic processing, vaccine production, quality control or quality assurance.
You demonstrate good organizational skills
You are results and customers oriented
You have proven ability to work cross-functional teams and projects to obtain desired business objectives
You show good analytical and problem-solving skills
You a strong communicator and can communicate effectively with different departments
Fluent in French and good knowledge of English
Preferred Qualifications :
Experience in Project management
You have a first experience in a matrix organization
Successful experience in Stakeholder management
Leadership, decision making, critical thinking and analysis of issues, impact and influence, innovative thinking, engage people, achieving excellence
Manages own time to meet agreed short-term targets
may propose new operating procedures Work across boundaries