The purpose of the role is to apply the GSK validation methodology to the manufacturing activities in the bulk production building.
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:
Responsible for the coordination of validation linked to the launch of New HAV facility and small projects linked to change controls related to equipment, systems such autoclaves, oven…or CIP, SIP, Mediabulk, or utilities (EDI, EPI, EUF, VP, ACP).
Responsible for defining and implementing an adequate validation strategy in compliance with FDA, EMEA and International quality standards.
Project Management: control/monitor planning of all validation activities linked to New HAV project (Microsoft project follow up) and Take corrective actions if necessary.
Responsible for ensuring and coordinating the support (planning, weekly validation, resources, cost) to change controls or projects.
Write and/or Review the validation documentation regarding the GMP requirements and the GSK Vaccines procedures (Protocols, Reports, Validation Plan, Validation Summary Report, Risk Assessment, Gap Analysis , Periodic review ….).
Manage deviations and out of specifications: bring expertise and help in investigating and solving issues and associated CAPA.
Ensure correct and state of the art Validation approaches for change controls from Design Qualification step to the establishment of the Validation Summary report (which is final approved by the QA). This accountability involves knowledge of the Validation Life-cycle process as well as in Specific Validation Strategies (i.e.Cleaning Validation, Aseptic Media Simulation…).
Participate as expert in external authorities inspections (EMEA, FDA, WHO…).
Responsible for assuring inspection readiness – regarding Validation – by Corporate GSK functions and RA authorities (FDE,EMEA,Canada).
Has developed at least one area of expertise and is recognized as such.
Bring expertise and coaching to streams.
Ensure coordination with all key players (local QA, Global QA, C&M, Streams rep,…).
Ensure the compliance on EHS topics in/outside his area and develop the EHS mindset within his team and peers.
We are looking for professionals with these required skills to achieve our goals:
University degree: master degree in Sciences/Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer pharmaceutical
Minimum 5 years in the Pharmaceutical/Biotech industry with significant experience of GMP
French fluent and professional writing and speaking in English are a must.
Preferred knowledge of vaccines and/or immunology process and products (manufacturing).
If you have the following characteristics, it would be a plus:
Expertise in validation, knowledge of International standards (CFR and Eudralex), GMP and Regulatory
Experience in Project Management
Successful experience in people management
Good knowledge in RA and prior approval establishment RA inspections is an asset.
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
Ensures the coherence between contributions / quality of final results and procedures, encourages reflection on the need to adapt/align procedures; may propose new operating procedures