Validation Project Specialist - Extractables / Leachables
A leading biotechnology company is advertising a vacancy for a Validation Project Specialist - Extractables/Leachables. The organisation offers cutting-edge products and services for the development, quality assurance, and production processes of the biopharmaceutical industry, covering fermentation, cell cultivation, filtration, purification, fluid management, and lab technologies. Based in Shanghai, this position is an exciting opportunity to work with an innovative and prestigious organisation that is strongly rooted in the scientific community.
- Establish and coordinate local E/L analytical testing capabilities.
- Ensure that customers receive quality data by reviewing study results for accuracy, clarity, and adherence to required regulatory standards.
- Provide monthly testing activity and performance reports.
- Promote Validation Services to local market (workshops, webinars, etc.).
- Support consumables business growth via cooperation with sales colleagues and application specialists.
- Visit customers to support acquisition of new projects, consultation on test scope, and present Validation Services.
- Execute internal and external trainings.
- Understand customer requirements and concerns.
- Coordinate validation projects on behalf of the customer in a timely manner according to the agreed test scenario as well as in compliance with regulatory requirements (NMPA, FDA, EMA, WHO, etc.).
- Engage in risk assessment based on science, technical considerations, and regulatory requirements in line with validation philosophy and globally harmonized test methods.
- Prepare quotes for different test scenarios.
- Prepare, review, and approve scientific and technical validation documents (statements, protocols, reports, and other documents) in English and Chinese.
- Track validation leads and projects via different tools and provide summary reports as needed.
- Proactively participate in continuous improvement activities, e.g. optimisation of document templates or process flow as necessary.
- Articulate to customers and in projects the regulatory framework as relevant to both the customer's milestones as well as the respective technologies.
- Formulate and execute action plan of how technologies and services can help achieve the customer's or the project's regulatory goals.
- Perform regulatory surveillance on E/L topics and share up-dates with internal stakeholders.
Skills and Requirements:
- A minimum of a Master's Degree in Analytical Chemistry or equivalent; PhD is highly desirable.
- A minimum 3-5 years' experience in Life Science Industry or Contract Laboratory in the field of Extractables/Leachables testing.
- Proven experience in:
- operating analytical separation and identification techniques like HPLC-UV, GC-MS, LC-MS, ICP-MS/OES including related data review and interpretation
- developing and validating analytical methods
- analysis of polymer-based materials
- performing investigations into the identity of unknown compounds
- risk assessment
- Familiarity with GMP and GDP (Good Documentation Practices).
- Good understanding of drug manufacturing processes and pharmaceutical industry regulatory requirements specifically in the field of Extractables/Leachables (NMPA, FDA, EMA, WHO etc.)
- Experience with filtration/single-use technology preferred.
- Experienced with Project Management and Teamwork in global environment.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Lily Zhao at +86 21 51694106 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.