Deviation Specialist

Jobinhalt

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Job Description

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 in-depth 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

• Good knowledge and understanding of manufacturing processes and used technologies
• 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

• 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.
• 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.
• 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 business drivers and customer needs; engage and align investigation team members from different departments.
• Analysing Obtain accurate and complete information about people, situations and problems. To analyse the links that are formed, thus gaining a clear view of the factors underlying the problem and how these factors influence each other. Actively engaged in in continuous improvement initiatives; comfortable with analysis and interpretation of data; knowledge of statistics (methods, tools, concepts, …) for investigational purposes.
• Being creative Find original solutions to situations and propose better alternatives to existing solutions. Think out-of-the-box. Eager to learn new technologies; demonstrate interest in and understanding of used equipments and technologies; brings out-of-the-box solutions to problems.
  

More About Us

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.

Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.

Empowering our people to shine

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information, or characteristics, marital or other status. At Takeda, we embrace diversity as a whole.

Locations

BEL - Lessines

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time