CMC Associate

MAIN RESPONSIBILITIES

·  Prepare CMC regulatory documents within established timelines(Modules2.3&3.2,IMPD,variations)

·  Analyzeand/orwritescientificreportsfromtheraw dataprovidedbytheclient.

·  Regulatory compliance: comparison of analytical proceduresand/ormanufacturingprocessbetween MAdossierandmanufacturingsiteprocedures.

·  Applyinternalprocessesandtemplatesaswellasbest practices of theprofession

·  Reportanydeviationorissuetoyourmanagerand proposecorrectiveorpreventiveactions.

·  Provideon-goingsupporttotheCMCLeaderandto projectteamstoensurethatprojectobjectivesaremet.

·  ContributetodataentryinPLGtoolsenabling measurements ofKPI

·  AssistinthepreparationorupdateofStandard Operating Procedures (SOPs) and Working Practice Documents(WPDs)

EDUCATION & EXPERIENCE

u  DegreeinlifeScience/Pharmacyrelatedfield

u  0-2yearsofexperienceinCMCand/orQuality AssuranceinPharmaceuticalIndustry

SKILLS

u  FluentinEnglish/French(written&spoken)

u  Excellent attention todetail

u  Abilitytoworkwellwithinateam

u  Good time managementskills

u  Abilitytoworktotightdeadlines

u  Processoriented

u  Excellent communicationskills