- Bio-engineer or University degree in Microbiology or equivalent acquired through experience, phD is a plus
- High knowledge in microbiology, aseptic practices and associated regulations (Eudralex, FDA & CFR, PICs…)
- Good understanding of pharma industry microbiological testing (Bioburden, Sterility, Endotoxins, Disinfectant efficacy, Mycoplasma…) and Environmental Monitoring
- Good knowledge in microbiology test validation principles. Rapid /Alternate Microbiology methods is a plus
- Good knowledge of GMP for biologicals products
- High level of written and spoken English
- High level of flexibility, sense of priorities, communication and good organizational skills.
- Lean culture knowledge is a plus
- Required Hard Skills:
o Project management
o Risk analysis techniques
o Root Cause Analysis and overall Investigation/deviation techniques
o Cleaning & Disinfection (including VHP, Dry-fog…)
o Sterile Isolator Technologies
o Facilities, engineering (including HVAC…)
o Aseptic practices and associated regulations
- Required Soft skills:
o Mentoring/coaching, knowledge management and transfer & training
o Lean Management and Continuous improvement: Shop-floor, gemba, Problem Solving
o Multi-disciplinary/matrix team work
o Change management
o Impact and Influence
Description du département:
2. Job Purpose:
- Transversal support to QC partners dealing with aseptic activities.
- Accountable for QC specific policies/rationales in the field of aseptic, external stakeholder management.
- Accountable for QC successful aseptic activities regarding practices, viable and non-viable performances
- Manage QC projects in the field of Aseptic/Microbiology
- Key-contact for Stakeholders in the field of aseptic activities and QC related activities
3. Key Responsibilities:
- Motivates and encourage QC and QA teams to achieve maximum performance in terms of environnemental monitoring
- Provide technical support to Aseptic QC and QA teams and is Single point of contact for Aseptic practices, QC specificities, general Microbiology within department (Quality Control) and for external stakeholders
- Organization and monitoring of performance progress efficiency of the teams through performance indicators releated to Environmental monitoring
- Ensuring compliance of the operations with GMP, Authorities and industry standards requirements in collaboration with QA
- Apply GSK processes and Pharmacopeia requirements
- Support EHS aspects
- Anticipate potential improvements, Implementation of correctives and preventives actions
- EM Deviations management
- Change control management
- Project Management
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is 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.
GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.
For further information, please visit www.gsk.com.
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