Product Transfer Senior Specialist
* Requisition ID: WD170930
* Position: Full-Time Regular
* Open date: Jun 12, 2018 10:08 AM
* Functional area: Quality
* Required degrees: Not Indicated
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In 2010, the GSK Vaccines manufacturing network was mainly concentrated on 2 Belgian sites.
Manufacturing capacity outside Belgium was gradually ramped up with Bio sites in Europe, US and Asia, but also through an External Supply manufacturing network. In the near future, through new joint ventures and project launches in emerging markets (e.g. China, India) the network will be expanded and technology transfer workload will increase. The Product Transfer Senior Specialist will be responsible to the oversight of Product Transfer projects impacting 10 out of the 18 GSK Vaccines sites.
* Based on the project portfolio, support the overall activities of deployment (routine operation, field, technical support, and validation) for primary and secondary processes.
* Coordinate the adequate support from design phase till handover. Support will be provided on the following areas : media preparation, primary processes (upstream and downstream processes) secondary processes (formulation, filling, visual inspection, packaging, aseptic processes) transversal support (HVAC, environmental monitoring, clean utilities, Extractable & Leachable, bioburden, homogeneity, inactivation, filters, cartridges life time etc.) and risk assessment.
* Act as validation and technical expert for international projects providing all technical information to the SPOC of Product Transfer.
* Provide the adequate training support to the receiving sites (field knowledge, day to day activities etc.) and be member of the induction technical team.
* Define with the local site the validation strategy and planning for all transversal validations by involving the local validation and QA.
* Support the receiving site to establish all maintenance and requalification programs.
* Manage any potential issues and if necessary escalate it to the Product Transfer project leader or SPOC.
* Define with the local and regional QA the adequate GMP standards, integrating the local regulations.
* Support and if necessary lead the local team in case of deviation and CAPA definition related to the technical field.
* Deploy and adapt the latest validation standards in accordance with the Centre of Excellence team requirements and provide to the Expert any deployment issues.
* Ensure the adequate transfer of all Quality alert into the Product Transfer network.
* Coordinate the QC validation of equipment including transversal equipment (Autoclave, clean utilities, GMP washer, Incubators, thermostatic rooms etc.).
* Support the users/sites by frequent site visits and teleconference.
* Ensure the availability of all documentation required to support the validation from the donor sites or from the existing library.
* Approve the cornerstone documents during the project, support the receiving site for audit documentation and inspection readiness.
* Prepare the local team during audits.
* Liaise with Engineering Shared Services when support is requested for custom-designed process equipment.
* Act as SME for some topics (e.g. Environmental Monitoring, aseptic manipulations, overall validation V-Cycle, Commissioning).
Why You?Basic qualifications:
* University degree in Pharma or Biotechnology field
* Scientific and technological know-how related to vaccine manufacturing
* Strong Project Management skills
* Expertise in vaccine products
* Experience managing multiple, complex transfer projects
* Strong knowledge of aseptic operations
* Knowledge of international regulations (e.g. FDA, PIC's, WHO, Eudralex and local cGMP)
* Agility to adapt to rapidly changing environment
* Ability to work efficiently in a complex, matrix organization, operate cross-functionally in a global environment, build and sustain personal relationships at 360°
* Excellent communication and negotiation skills
* Cultural sensitivity to effectively deal with a variety of languages and local cultures
* Anticipate problems/issues during transfer and ability to advise solutions
* Considerable autonomy in the approach to meet the objectives and deliverables
* Pro-activity and dynamism, resistance to stress
* Influencing ability to build trusting relationships and gain support within the different departments
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 Industrialisation (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.