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.
Validation of Method, Analytical Equipment and Software
- Write validation Protocols, Technical Reports, Deviation Reports.
- Plan validation activities with local QC
- Assures GMP compliant and timely execution of validations
- Coach/lead validations (incl. S&R and CC), focus on complex topics, involving other sites/functions outside QC
- Establish and maintain validated status of assays and equipment
- Subject 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
- DP site SME (local training, communication site/DP owner)
- Perform trending for laboratory invalid tests
- Lead and drive investigations (OOS, Lab invalids, etc)
- Identify, lead and drive improvements or remediation of assays
- Leads problem solving and improvement projects for troubled assays (OOS, CAPA, etc)
- Knowledge sharing of problems that found and share solutions to drive continuous improvement
- Provide training and consulting
- Prepare documents for qualification plan/ report and calibration plan/report for S&R as required
- Prepare 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 required
- Maintain the schedule for compendia reviews
- KPI fulfillment and Support global harmonization and simplification
- Coordinates a subset of team members or entire group for specific tasks/topics/projects
- QC 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 equivalent
- At 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/investigations
- Team player and independent contributor
- DMAIC tools experience
- Presentation skills for training and audits and Senior Management
- Experience in problem solving (facilitation and application of tools)
- Basic statistical knowledge and experience with data analysis
- Knowledge concerning cGMP, especially lab related topics as method validation, OOS, critical reagent qualification, equipment and software validation life cycle
- Basic knowledge about regulatory requirements concerning analytical test methods and licenses
- Has substantial knowledge and understanding in terms of regulatory standards requirements e.g. USP, EP, 21CFR, ICH etc.
- Knowledge in Microsoft Office
- Project Management Skills
- Communication and organizational skills
- Strategically and Business oriented thinking
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire, a wholly-owned subsidiary of Takeda and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.