Analytical Scientist

Entreprise :

The Adecco Group Switzerland

Description du poste :

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