Your Responsibilities : Job Purpose :
Job Purpose :
The Project Validation Coordinator is accountable to coordinate validation activities in collaboration with Quality Assurance, Producer, Technical Service, Quality Control and Expert.
Key responsibilities :
Coordination of the validation of projects in Primary or Secondary Technical R&D (TRD) GMP Manufacturing.
Ensure correct and state of the art Validation approaches, be responsible, with the coaching of the N+1 or a colleague, to establish the Validation Plan and be accountable for all GMP decisions taken during the Validation of the project starting with the Design Qualification step and ending with the establishment of the Validation Summary report.
Writing, reviewing and approving validation documents (Risk Assessment, Product Quantity (PQ) Protocol, PQ Report, ).
Coordination of PQ execution activities.
Implementation of the validation guideline and SOP for the processes & equipment (Validation life-cyle process, Qualifications, Process Validation).
Ensuring, during the design and validation steps, (until the end of consistency lots) for the facility project, writing, an independent review and first approval of validation documentation.
Participation to perform the writing of the facility submission files for the projects.
Participate, for the validation sections, in external authorities inspections (EMEA, FDA, WHO ) with the coaching of the N+1.
Implementation of adequate validation strategy in compliance with FDA, EMEA and international quality standards.
Assuring inspection readiness regarding Validation by Corporate GSK functions and RA authorities (FDA, EMEA, Canada) with the coaching of the N+1.
Basic qualifications :
University degree in Biology, Biochemistry, Chemical Engineering, Bioengineering, Pharmacy, or other relevant discipline.
At least 1-2 years experience in aseptic processing or vaccine production including knowledge of the scale up principles, quality control tests, production technologies and Good Manufacturing Practices (GMP).
Familiarized with GMP environment and in validation activities
Knowledge in PQ validation and GMP, Skills in a matrix organization, strong communication, organizational and influencing skills to work transversally.
Fluent in French and good knowledge in English are a Must.
Preferred qualifications :
Please see "Basic Qualifications".
Why GSK? : Our Company :
Our Company :
GSK one of the world’s leading research-based pharmaceutical and healthcare companies is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
The Department :
GMP Manufacturing and Clinical Supply (GMP Mfg.) is critical to produce Clinical lots, robust product, process development and launch of novel vaccines.
At GSK we value diversity and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution.
If you require a reasonable adjustment to the application / selection process to enable you to demonstrate your ability to perform the job requirements you will have the opportunity to let us know what specific assistance you require.
This will help us to make suitable arrangements to support you throughout our selection process.