Primary Objectives of this Job                      

This position is required to perform all tasks associated with the Global QC lab operations which include deviation/investigation write up/review, equipment qualification, method validation, method transfer and other tasks as assigned.

Responsibilities

Validation of Method, Analytical Equipment and Software

Write validation Protocols, Technical Reports, Deviation Reports.Plan validation activities with local QCAssures GMP compliant and timely execution of validationsCoach/lead validations (incl. S&R and CC), focus on complex topics, involving other sites/functions outside QCEstablish and maintain validated status of assays and equipmentSubject matter expert in instrumentation and technical functions e.g. method validation/transfer, lab equipment etc.  Provide technical advice to Local QC in laboratory related troubleshooting, e.g. lab equipment failure

Other Responsibilities

DP site SME (local training, communication site/DP owner)Perform trending for laboratory invalid testsLead and drive investigations (OOS, Lab invalids, etc)Identify, lead and drive improvements or remediation of assaysLeads problem solving and improvement projects for troubled assays (OOS, CAPA, etc)Knowledge sharing of problems that found and share solutions to drive continuous improvementProvide training and consultingPrepare documents for qualification plan/ report and calibration plan/report for S&R as requiredPrepare control assignment Protocol/Report for controls as required.Support audit preparation, present investigation/issues and MI&S documents at audits as required.Prepare/ revise regulatory submission documents and  MoH responses e.g. CVR (Consolidated (Test) Validation Report) and annual report as requiredMaintain the schedule for compendia reviews

General Responsibilities

KPI fulfillment and Support global harmonization and simplificationCoordinates a subset of team members or entire group for specific tasks/topics/projectsQC specialist may cover for another QC specialist of similar functions/areas in his/her absence signing documents on his/her behalf.Responsibility to adhere to any applicable EHS requirements.Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda’s Code of Conduct.Any other duties as assigned by supervisor.

Education and Experience Requirements

Bachelor Degree in Chemistry, Biochemistry, Biotechnology or equivalentAt least 1 years of experience in Pharmaceutical, Biopharmaceutical or related manufacturing environment.Six Sigma Greenbelt training would be helpful.Demonstrated strong technical experience e.g. in the area of method validation, method transfer, equipment qualification, OOS investigation.Demonstrated ability to collaborate with cross functional or cross sites to achieve objectives.

Key Skills and Competencies

Experienced validation know-how, independent lead/Decision driver within validations/investigationsTeam player and independent contributorDMAIC tools experiencePresentation skills for training and audits and Senior ManagementExperience in problem solving (facilitation and application of tools)Basic statistical knowledge and experience with data analysisKnowledge concerning cGMP, especially lab related topics as method validation, OOS, critical reagent qualification, equipment and software validation life cycleBasic knowledge about regulatory requirements concerning analytical test methods and licensesHas substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.Knowledge in Microsoft OfficeProject Management SkillsCommunication and organizational skillsStrategically and Business oriented thinking