QC Instrument and software validation specialist

Takeda Neuchâtel
place
Neuchâtel

2T

Online bewerbenopen_in_new
Job Description
Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site

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.

QC Instrument and software validation specialist

Job Description
Takeda Neuchâtel

Site de Production Biotech | Biotech Manufacturing Site

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.

QC Instrument and software validation specialist (100%)

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.

Job summary

The job holder is accountable for the Analytical Instrument Qualification (AIQ), 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

  • Comply with cGMPs and DI requirements through applicable guidelines and procedures

  • Represent the QC department on project core teams and participate in strategy discussions

  • Review and evaluate design documents and reports

  • Author validation plans, protocols, and reports

  • Oversee validation activities executed by QC analysts, provide training and support

  • Support and interface with process owners of laboratory systems

  • Maintain validation status of analytical instrument, including computerized systems

  • Provide technical assessments on change controls, deviations, and investigations

  • Maintain site validation master plan

  • Create/maintain validation related SOPs and WI documents

  • Support and prepare inspections, audit responses and regulatory submissions

Education & Experience

  • Master’s in Engineering, Computer Science, or related technical field

  • Minimum of 5 years of relevant validation experience in the biotechnology or pharmaceutical industry

  • Extensive experience with validation life cycle requirements for cGMPs laboratory systems

  • Experience in dealing with audits/inspections with the FDA, other notified bodies, or Health Authority

  • Fluent in French and English (C1 written and spoken)

Qualifications

  • Detailed understanding of DI requirements and standard regulations for cGMPs operations

  • Strong team member with demonstrated ability to work effectively on cross-functional teams

  • Ability to work independently in a fast-paced environment and manage multiple projects and priorities

  • Effective organization, communication, presentation and influencing skills