Validation Specialist (Automated Visual Inspection)
* Requisition ID: WD166630
* Position: Full-Time Regular
* Open date: May 4, 2018 11:06 AM
* Functional area: Engineering
* Required degrees: Not Indicated
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Job purpose and Key Responsibilities :
Responsible for the validation and quality strategy for Automatic Visual Inspection and leak detection within the MPU FVI.
* Responsible for the facilitation of the vision Engineering work to assure we are identifying, prioritizing and mitigating quality threats related to automated vision inspection and leak detection.
* Responsible for defining/updating and monitoring preventive maintenance, inspection and calibration programs
* Ensure correct and state of the art validation approaches
* Responsible for the deviation strategy for automated vivion inspection and leak detection
* Investigation to lead in case of deviations with production , QA and maintenance team.
* "Deviation fronter" during inspections
* Sees logical relations: identifies links between different components of a problem or situation
* Develops team's perspective & knowledge for cGMP's aspects
* Lead investigations and trials related to process improvement for vision (on the AVI machines and on the upstream process). Propose solutions for improvement.
* Participate in communities of AVI and LD practices team, to exchange and share best practice knowledge for validation and change control
* Give support to the others departments during Authorities Inspection
* Respects current Good Manufacturing Practices (CGMP) as well as GMP procedures.
* Leads the deviation process (root causes identification and selection of CAPAs in order to avoid recurrence of deviation with technical root causes).
* Documents deviations by integrating changes to maintenance operations.
* Resolves audit actions in relation with his knowledge scope.
Why You?Basic qualifications:
* At least 3 years experience in validation / deviation processes
* At least 5 years experience in pharmaceutical environment
* Scientific background
* Visual inspection; vision systems
* Deviation process / Validation process
* Excellent communication and negotiation skills
* Sense of urgency and
* Ability to discuss technical matters with engineers and summarize concepts into quality system
* English. French
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.