Manager - Project Validation
* Requisition ID: WD156166
* Position: Full-Time Replacement
* Open date: Mar 10, 2018 2:57 PM
* Functional area: Manufacturing
* Required degrees: Not Indicated
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GMP Manufacturing and Clinical Supply (GMP Mfg.) is critical to produce Clinical lots, robust product, process development and launch of novel vaccines. The Validation Manager is accountable to lead the validation team in supporting, in term of validation, clinical manufacturing activities and CAPEX projects in collaboration with Quality Assurance, Producer, Technical Service, Quality Control and Expert.
- Responsible for managing the team of the validation coordinators (internal and external) and budget for several projects on GSK Vaccine site.
- Responsible for managing the team of the validation coordinators (internal and external) and budget to maintain the validated state of Technical R&D (TRD) GMP M&CS facilities.
- Accountable for execution and tracking (planning, validation committee participation) of several TRD projects from the validation plan step to the Core file approval.
- Accountable for execution of transposable validation related to product life cycle (e.g. filter validation).
- Develop validation expertise within his/her team in order to be recognized as single point of contact for validation activities.
- Ensure correct and state of the art validation approaches, be responsible for establishing the validation plan, Performance Qualification, risk assessments, gap analysis, validation summary reports and for all other GMP decision taken during the TRD GMP M&CS projects
- Responsible for the implementation of the validation policies for the processes & equipment, for ensuring the associated coaching within the project team (Validation life-cycle process, Qualifications, Process Validation and computer related systems validation).
- Responsible to ensure, during the design and validation steps of the TRD GMP M&CS project, an independent review and first approval of validation documentation.
- Responsible for assuring inspection readiness and participating, for validation aspects, in internal audits (including Corporate GSK) and external authorities inspections (European, US FDA, WHO, …).
- Responsible for the definition and implementation of adequate validation strategies in compliance with US, European and International quality standards.
- Responsible to manage and maintain the validation processes in TRD GMP M&CS.
- Responsible to manage all the connected processes to validation activities like KPI, Deviation, Change Control, CAPA management.
Why You?Basic qualifications:
- Advanced degree in Process Engineering sciences, pharmacy and/or sciences in general, or equivalent experience.
- At least 7 years experience in Aseptic Processing or vaccine production including knowledge of the scale up principles, quality control tests, production technologies and Good Manufacturing Practices.
- Knowledge in PQ validation and GMP.
- Fluent in English & French are a MUST.
- Skills in a matrix organization, project management and people management
- Strong communication, organizational and influencing skills to work transversely.
- Sense of urgency and effective time management to be able to manage multiple projects at different time points.
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.
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialization (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.
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.