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Analytical Scientist

Ref: JN-052021-178481

Gepostet am 08 June 2021
Job Location
Neuchâtel
Kategorie
Life Sciences

Modis Life Sciences is looking for one of it's clients a:

·        Support the approval and qualification process

·        Review raw data (QC peer review)

·        Coordinate sample shipment between sites

·        Participate in the inspection/audit at Contract Service Providers

·        Provide support to Vendor during Health Authority inspections

·        Perform QC oversight of commercial Vendors as appropriate

·        Perform Analytical release as appropriate, issuing internal Certificates of Analysis and data conformity statements

Support laboratory investigations, deviations, CAPA’s, Change Controls

·        Ability to troubleshoot method and/or equipment issues to the root cause

·        Capable of resolving non-routine laboratory issues and problems expeditiously

·        Interacts with Vendors, reviews raw data generated by Vendors during investigations and supports their lab investigations as needed

·        Ability to write analytical method risk assessments or regulatory impact assessment statements (RIAS)

·        Proposes meaningful, cost-effective CAPAs to address root causes

·        Able to raise Change Controls with the appropriate supporting data package

·        Participates in audits and interacts and answers questions from Heath Authorities

GQAST-related tasks

·        Support Validation of Analytical Methods or Tech transfer

·        Conceive experiments to evaluate analytical methods associated with commercial products for investigation, method improvement, remediation and/or troubleshooting.

·        Write formal analytical documents such as validation protocols, method transfer protocols and investigations reports.

#boost

·        M.S. Biochemistry, Biology, Biotechnology, or relevant discipline with a focus on analytics

·        2 years of relevant work experience required, preferable in a pharmaceutical GMP environment

·        An equivalent combination of education and experience may substitute

·        Advanced knowledge and interpretation of cGMP

·        General understanding of analytical validation and technical transfer concepts and requirements

·        Advanced written and verbal communication skills

·        Strong problem-solving ability/mentality, technically adept and logical

·        Ability to interface with Regulatory Authorities and Contract Service Providers

·        Knowledge of international analytical regulatory requirements (PIC/S, USP, Ph.Eur, JP, FDA (21CFR Part 11, 210 and 211), Annex 11 (EU-GMP), ICH, and Good Automated Manufacturing Practice (GAMP)

·        Advanced knowledge of laboratory and aseptic processes

·        Ability to work independently, and/or lead and participate in team projects

·        Advanced knowledge of Microsoft Word, Outlook, and Excel, Project, and Visio

·        Requires presentation development and delivery skills

Ability to understand aseptic processes