CSV/DI & Laboratory Equipment Qualification Specialist
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CSV/DI & Laboratory Equipment Qualification SpecialistApply Now
Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine.
Here, everyone matters, and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.
An exciting and challenging opportunity has become available at Takeda Neuchâtel Plant (approx. 650 employees) for a Quality Control Equipment Qualification Specialist.
This is an exciting career opportunity for a dynamic, autonomous, continuous improvement minded and change agile professional to embrace a team-based culture and more specifically within the Quality Control teams within a world-class Biotech GMP manufacturing environment.
The job holder is accountable for the laboratory instruments qualification, including Computerized System Validation (CSV) in the QC laboratories of Neuchâtel - Switzerland. In addition, the job holder also supports the deployment of Data Integrity (DI) in the department.
Essential duties and responsibilities
- Ensure computerized system validation strategy within QC department as well as providing laboratory equipment validation expertise
- Comply with GMP and Data Integrity requirements through applicable guidelines and procedures
- Define and follow-up the CS Validation Strategy (Validation Plan)
- Review / Approve User System Requirement (URS), Functional Specification and Design Specifications
- Lead Risk Assessments
- Write Design Qualifications
- Writing qualification protocols (IOPQ) and reports for quality control instruments, including computerized systems
- Ensure the readiness of instruments for validation activities (i.e. with feasibility protocols)
- Support analytical technical transfer of assays requiring Analytical Instrument Qualification activities (AIQ)
- Oversee qualification activities executed by QC analysts, provide training and support
- Coordinate instruments periodic review
- Support and prepare inspections, audit responses and regulatory submissions
Education & Experience
- Bachelor or engineering degree in a technical field
- Min 3 years of experience in Analytical Instrument Qualification (AIQ) and Computerized System Validation (CSV) activities
- Experience in GMP laboratory activities and good knowledge of Data Integrity requirements
- Fluent in French and English (C1 written and spoken)
- Excellent computer skills (Word, Excel, Power Point, MS Project)
- Able to set his/her own priorities and tight timelines
- Good interpersonal, organizational, and communication skills
- Ability to synthesize information and defend conclusions publically
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.
Job ID SR0038573