Quality Control Validation Specialist (2 years duration contract)Apply Now Email Me Job ID SR0032651 Date posted 02/04/2019 Location:Neuchâtel, Switzerland
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 Validation 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 validation and the transfer of analytical and microbiological assays performed in the QC laboratories of Neuchâtel - Switzerland. In addition, the job holder also supports laboratory equipment qualification.
Essential duties and responsibilities
- Comply with GMP and Data Integrity requirements through applicable guidelines and procedures
- Responsible for writing validation protocols and reports for analytical and microbiological methods
- Responsible for writing qualification plans and reports for critical reagents and reference standards
- Oversee validation and qualification activities executed by local QC, provide training and support
- Responsible for analytical method transfers between Analytical Development and Quality Control laboratories as well as within Operations
- Support laboratory equipment qualification and ensure the readiness for validation activities (i.e. with feasibility protocols)
- Write assignment plans and reports for method controls, establish and perform evaluation of control charts
- Support and preparation of audits, audit responses and regulatory submissions
Education & Experience
- University or engineering degree in analytical chemistry, biochemistry or biotechnology
- Min 3 years of experience in GMP pharmaceutical business activities
- Experience in GMP laboratory activities, preferably with a good knowledge of Data Integrity requirements
- Good knowledge of analytical method validation and critical reagent qualification
- Good knowledge of regulatory requirements concerning analytical test methods and licenses
- Fluent in French and English (C1 written and spoken)
- Excellent computer skills (Word, Excel, Power Point, MS Project)
- Knowledge of advanced statistical tools (i.e. sample size determination, control charting, capability, and design of experiments)
- Able to set his/her own priorities and tight timelines
- Good interpersonal, organizational, and communication skills
- Ability to synthesize information and defend conclusions publically
Living our leadership behaviors is a basic expectation for all Takeda employees. Takeda expects all employees to embody the following:
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