Job Description

About the role:

The Lead Investigator will initiate and complete deviations to support Manufacturing. Responsibilities include defining problem statements, documenting current state, conducting root cause analysis, implementing corrective actions, and verifying that the corrective actions were in resolving the issue. You provide technical support to the manufacturing functions which includes filling, inspection, and packaging operations. Also, you will work with the corresponding manufacturing, quality assurance, or important system personnel to investigate suspect results. Responsibilities include leading investigation teams and driving cause identification and preparing presentation for management.

How you will contribute:

• Conduct and document Investigation promptly to support the closure of non-conformances to meet product fulfillment dates.
• Support problem solving sessions through application of the tools and methods to lead investigation teams. Lead routine and complex investigations.
• Contribute to a team setting, increase efficiency, create cost savings, improve quality, and provide new product support. Lead Deviation Free Programs
• Work with other QA departments and manufacturing operations to conduct investigations, determine appropriate corrective actions, and lead closure of deviations following cGMP and quality systems.
• Maintain access to main quality system databases and ensure accuracy of those databases as they pertain to CAPA and other quality databases.
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Investigate deviations and write exception documents, when assigned.
• Ensure training requirements are met and that training records are current. Train other team members and support training for newer team members.
• Prepare cause and trend analysis to management during routine operation mechanisms (e.g., Management Review and CAPA Review Board).
• Active Yellow Belt Certification
• Understand scientific strategies and be able to create new processes or new avenues of investigation.
• Will understand and apply cGMP/GOP, follow CTP/SOPs, and meet EHS requirements.
• Demonstrate good process and important system understanding to create comprehensive investigation write up.
• Navigate through Quality systems and has working knowledge of event management system.

What you bring to Takeda:

• Typically requires a bachelor’s degree in science, engineering or other related technical field and 2+ years of related work experience. Some leadership experience.
• Technical writing experience.

Important Considerations

At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. You may:

• In general, your work will be a combination of sedentary work and walking around observing conditions in the facility.
• May sit and operate computer frequently and for extended periods of time.
• May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• May work in a cold, hot or wet environment.
• May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
• Can work , flexible hours, including weekends and holidays to support a 24/7 site.
• May work or be assigned to a different shift.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and the best patient support programs. Takeda is a patient-focused company to 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.

#GMSGQ

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How to Apply

Job Types: Full-Time. Salaries: Not Disclosed.

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