Deviation Specialist
il y a 1 semaine
About the role:
Integrated in the Manufacturing Investigation Team and within the scope of manufacturing (Purification, Filling, Packaging, Engineering, Environmental Monitoring (EM)), the Deviation Specialist leads investigations related to high risk quality deviations.
He/She will be responsible to investigate and document the investigations, identify root causes to an event, evaluate the quality impact, write an investigation report and coordinate the development and implementation of action plans necessary to avoid reoccurrence.
He/she will treat the deviations in a timely manner and will establish an effective communication with the involved experts and customers.
How you will contribute:
- Performs structured and indepth investigations to identify root causes of medium to complex issues, using the right investigation tools
- Provides the required SME input (technical and/or scientific skills)
- Evaluates the quality impact together with the quality department, analyses reoccurrence, identifies and assures implementation of robust action plans to ensure elimination of root causes
- Leads gemba's, identifies and engages with the right teams to investigate the event thoroughly
- Writes investigation reports in a structured, rigorous and detailed manner (narrative style) and documents timely and correctly in Trackwise
- Is responsible to meet the sites' target KPI's
- Communicates effectively with the expert departments and customers (QA Ops, Engineering, Maintenance, Metrology, Environmental Monitoring, Exception Management, Manufacturing, )
- Is able to present problem statement, status of investigation and proposed CAPA in a clear, concise and autonomous manner at deviation boards
- Ensures a supportive role during presentation of deviations in audits
- Brings investigation teams together and ensures collaboration, engagement and alignment of the teams
What you bring to Takeda:
- Master in Engineering or Science or equivalent by experience
- Minimum 3 years of relevant experience
Hard skills:
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Good knowledge and understanding of manufacturing processes and used technologies
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Good knowledge of Quality requirements (SOPs, USP, FDA, Eudralex,)
- Good level of investigation capabilities
- Good (technical) writing skills
- English knowledge
:written good, spoken intermediate - Good knowledge of MS Office (Word, Excel, PowerPoint)
ERP system
- JdE
- Knowledge of structured analyses (6M, 5 Why, FMEA, DMAIC )
- Knowledge of statistics for investigational purposes
Core Competencies:
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Working together:_Have a vocation to work together and to involve other team members in this dynamic in order to achieve common goals._
Good interpersonal skills; team player; sharing of positive outcomes and lessons learned within and beyond the team; regular cooperation with QA Ops, Engineering, Maintenance, Metrology, Environmental Monitoring, Exception Management, Production; actively participate in an investigation team including different departments and different opinions.
-Organising and planning:_Develop a clear plan of action, based on objectives that are coherently structured, with a defined period of time in which the objectives are to be achieved in the most effective way possible._
Applies a rigorous and structured approach when handling quality deviations; defines an action plan with action owners and ensures follow-up; ensures timely logging and documentation of decisions, progress, actions,; coordinates investigation stakeholders in order to ensure timely completion of actions.
-Persuading:_The ability to gain the support of others for ideas, activities through well-founded arguments in order to increase effectiveness or to mobilise them towards the desired goal._ Expresses ideas, updates, initiatives and concepts in a clear, confident and concise way; achieves alignment on deviation approaches between different implicated dpts.
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Problem solving:_Have a good understanding of practical issues, use the right information and process it correctly._
Asks the right questions on deviation related topics in order to clarify the source of the issue; works systematically and diligently when gathering information; stress resistance.
-Decision making: _Adopt a certain point of view or define concrete actions at the right time, while taking into account their consequences and weight, within the framework of the objectives set. Take on accountability and ownership._
Full autonomy on decisions related to the handling of medium to high risk deviations.
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Leadership:_To be able to influence and coach people effectively in relation to the objectives being pursued. Aim for effectiveness and efficiency by consciously and thoughtfully intervening in the process and dynamics of the group._
Embrace and adopt the Takeda Leadership Behaviors _(Think Strategically, Inspire Others, Deliver Priorities and Elevate Capabilities);_ good understanding of busine
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