Senior Specialist Deviation/CAPA Champion
* Requisition ID: WD152798
* Position: Full-Time Regular
* Open date: Feb 13, 2018 1:34 PM
* Functional area: Manufacturing
* Required degrees: Not Indicated
Select Locale Email a friend
The Deviation/CAPA Champion assures the overall quality and effectiveness of the deviation and CAPA process within a MPU/SPU. He/she ensures best practices are in place and in use, seeks for continuous improvement, while ensuring application of the right level (risk-based approach) of quality. Finally, he/she assures capabilities buildup within the MPU/SPU through effective coaching, monitoring/reporting, and performance management. MPU/SPU will include QA & Operations
Key Responsibilities (among others):
- Responsible for the effectiveness of the Deviation and CAPA processes (lean and efficient)
- Co-responsible with the MPU/SPU Head for the progressive reduction of deviations through adequate root cause analysis and implementation of effective CAPAs
- Provide overall deviation and CAPA content assessment through application of adequate methodologies, i.e. START. Based on content assessment provide mentoring to ensure progressive capabilities build-up within the MPU/SPU
- Ensure certification and decertification process is in place and in use within the MPU/SPU for those managing deviations
- Ensure adequate Key Performance Indicators and processes ( i.e. tier meeting, deviation review board, …) are in place and in use to monitor, track, and drive progress with respect to i.e. human errors, recurrent deviations, deviation overdue, CAPA overdue, CAPA efficiency and CAPA effectiveness checks
- Escalade risks, problems, proposing action plans to Leadership Management Team for decisions regarding deviations & CAPA
- Analyse, lead and coordinate coaching or mentoring based on individuals' needs and business requirements, i.e. new standards, transversal procedure, etc.
- Evaluate applicability of best practices (deviations & CAPA) within the MPU/SPU and provide pro-active feedback for their implementation and use
- Be the local operational expert of the deviation and CAPA process and act as a coach for "deviation fronter" during inspections
- Actively contribute to driving cultural change, building up of capabilities and continuous improvement within the MPU/SPU
- Actively benchmark local practices (not included in Best Practices package) with other MPU/SPU, activate the network to anticipate changes/trends
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.
Why You?Basic qualifications:
- Master degree, preferably sciences with manufacturing and/or quality orientation
- 5 to 10 years of relevant experience
- Ability to understand business process management, and networking across the organization
- Ability to 'push', coach and mentor people to align with or change existing business processes, without hierarchical empowerment
- Having participated to Lean actions or organization projects is a plus
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.