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Job Description

About the role:

The incumbent will provide Quality Assurance support for Manufacturing process / Critical utilities and providing Quality oversight and manufacturing support. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Takeda quality practices. You will provide support to manufacturing using Electronic Batch Management (EBM) and guidance to other team members.   

The incumbent will be responsible to handle multiple projects, demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.  

How you will contribute:

• Responsible ongoing, daily departmental Quality Assurance support for Manufacturing process / Critical utilities. Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude through collaboration with production supervisors, engineering, and other internal groups. 

• Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.

• Review electronic batch records, identify nonconformance’s and participate in investigation and Corrective and Prevention Action (CAPA) activities

• Provide training and coaching to local employees and others as needed on relevant area(s). 

• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.

• Oversee review and audit of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)

• Participate in QA multi-site projects in the role of contributor, coordinator or lead.

• Other duties, tasks or projects as assigned.

• Must demonstrate critical thinking skills and understanding of the Manufacturing process and make Quality Decisions based on knowledge of regulations and regulatory trends.

• Works closely with Manufacturing, Manufacturing compliance, QC laboratories and Technical Services to ensure meeting the requirement of quality and safety of Final product.  

What you bring to Takeda:

• Requires Bachelors in Science / Business. In lieu of degree, 3+ years’ experience in Quality with a medical device/Pharma company or other similarly regulated industry.

• Must be a team player with good problem solving, and good verbal and written communication skills.

• Knowledge of TrackWise, Delta V and Electronic Batch Record Management preferred.

• Must be detailed oriented and have ability to multitask.

• Must be able to maintain metrics and drive team and external partners to meet.

• Metrics requirements.

• Strong interpersonal/communication/influencing/negotiation skills and great attention to details are necessary.

• Strong analytical and problem-solving skills.

• Must have the ability to encourage teamwork and drive decisions.

• Must be able to handle multiple projects concurrently.

• Must have adequate computer experience (knowledge of Microsoft Word, Excel and PowerPoint required.

• Knowledge of Electronic Quality Systems (TrackWise), process control.

• Systems (Delta V, BAS, PLC), Electronic Batch Record Management.