Analytical Validation- Supervisor (Quality) Job at Guerbet
At Guerbet, we build lasting relationships so that to enable people to live better. This is Our Purpose.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.
WHAT WE'RE LOOKING FOR:
The Analytical Validation Supervisor works with and oversees members of the Lifecycle Management team on a variety of projects. This position is responsible for performing stability testing, qualifying and distributing reference standards, writing SOPs and methods as needed, performing method development and validation tasks, as well as coordinating all of these activities for the other members of the LCM group under the supervision of the QC Laboratory management.
YOUR ROLE:
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.
We are a global leader in medical imaging, offering an extensive portfolio of pharmaceuticals, medical devices, digital and AI solutions, for diagnostic and interventional imaging. As a pioneer in the field of contrast products since the last 95 years ,we continuously innovate. We dedicate 10% of our revenue to Research & Development such as to improve the diagnosis, prognosis and quality of life of patients.
Achieve, Cooperate, Care and Innovate are the values that we share and practice on a daily basis.
Working at Guerbet is not only being part of a multicultural team of 2,600 people across more than 20 countries, but, it is above all about playing a unique role in the future of medical imaging.
For more information on Guerbet, go to www.guerbet.com and follow Guerbet on Linkedin, Twitter, Instagram and Youtube.
WHAT WE'RE LOOKING FOR:
The Analytical Validation Supervisor works with and oversees members of the Lifecycle Management team on a variety of projects. This position is responsible for performing stability testing, qualifying and distributing reference standards, writing SOPs and methods as needed, performing method development and validation tasks, as well as coordinating all of these activities for the other members of the LCM group under the supervision of the QC Laboratory management.
YOUR ROLE:
- Lead analytical project efforts, deliver project milestones on-time and on-quality, and represent analytical on cross-functional project core teams with representatives from Project Management, Chemistry, Engineering, Manufacturing, QC, and QA.
- Qualify and evaluate analytical methods for the transfer to cGMP Quality Control laboratory for method validation.
- Extensive hands-on experience and in-depth knowledge of 5 or more of the following analytical technologies including: chromatography (HPLC/GC/IC/UPLC/LC-MS/GC-MS), absorption spectroscopy, slope spectroscopy, FTIR, NMR, wet chemistry and/or USP, EP and JP methodologies.
- Excellent time management, attention to detail and strong communication skills (both written and verbal) are required. The candidate should be able to efficiently communicate concepts to both specialist and general audiences. Customer-facing experience is vital.
- Performs tests and assays via thorough understanding of laboratory standard operating procedures and instrumentation.
- Writes and revises new and existing testing procedures, instrument procedures, and laboratory documentation procedures.
- Performs experimental work under minimal supervision on future products and their respective testing procedures. Records and reports results and significant observations.
- Performs specialized testing and performs independently method development, validations and transfers.
- Ensure LCM group activities meet timelines provided by management.
- Provide technical expertise and troubleshooting assistance to QC lab with regards to investigations and aberrant results.
- Will provide support to Quality by performing the development and implementation of more efficient methods.
- Will provide support to Quality by answering technical questions and providing assistance with investigations and customer complaints, as needed.
- Will assist with the qualification and distribution of CMDS reference standards.
- Will assist with the creation of departmental SOPs and the revision of reference standard test methods.
- Will assist with special projects assigned to the Lifecycle Management group, such as new product introduction and compliance with new compendial and regulatory guidelines.
- Coordinate and supervise activities within the LCM group.
- PhD in Analytical Chemistry or Chemistry with >7 year, masters in Analytical Chemistry or Chemistry with > 10 years, or a Bachelor’s degree with >15 years of industrial experience is preferred
- Good interpersonal and verbal/written communication skills
- Able to use a computer for data analysis
- Able to lead a group effectively
- Ability to oversee multiple projects and ensure timelines are met
- Knowledge of laboratory safety, material safety
- Working knowledge of cGMPs, GLPs, and FDA
Please Note :
bankofmontserrat.ms is the go-to platform for job seekers looking for the best job postings from around the web. With a focus on quality, the platform guarantees that all job postings are from reliable sources and are up-to-date. It also offers a variety of tools to help users find the perfect job for them, such as searching by location and filtering by industry. Furthermore, bankofmontserrat.ms provides helpful resources like resume tips and career advice to give job seekers an edge in their search. With its commitment to quality and user-friendliness, Site.com is the ideal place to find your next job.