Reference Standard Scientific Project lead

il y a 3 semaines


Beerse, Flandre, Belgique Randstad Temps plein

In het Clinical Release and Stability (CRS)-team zijn we op zoek naar een Reference Standard Scientific Project-leider.

Het Clinical Release and Stability (CRS)-team is een cruciaal onderdeel van de afdeling Analytical Development in de Discovery, Product Development & Supply (DPDS)-organisatie binnen Johnson & Johnson Innovative Medicine. Het eigenaarschap van de referentiestandaard streeft naar een volledig wetenschappelijk inzicht in de referentiestandaardvereisten voor een project in alle klinische ontwikkelingsfasen.

In deze rol wordt de Lead Standard Scientific Project toegewezen aan verschillende ontwikkelingsprojecten waarvoor u alle referentiestandaardgerelateerde aspecten afhandelt en de 'go-to'-persoon bent als het gaat om de certificering van referentiestandaarden en gerelateerde vragen voor de toegewezen ontwikkelingsprojecten.

Stel je kandidaat voor een interessante job waarin je jouw skills als Reference Standard Scientific Project lead kan inzetten en verder ontwikkelen.

Bij Randstad Professionals - Life Sciences Vlaanderen word je lid van een groep geëngageerde collega's die zich inzetten voor heel wat topbedrijven in ons netwerk.

belangrijkste verantwoordelijkheden

Leidt en neemt waar nodig deel aan wetenschappelijke bijeenkomsten om teamdoelen te ondersteunen. Stelt zelfstandig en tijdig protocollen en CoA's op, op basis van chemische en projectkennis, conform de mondiale regelgeving en eisen. Coördineer analytische tests, ondersteun laboratoria (intern en extern) wetenschappelijk en beslis over COA (bijvoorbeeld opslagomstandigheden, datum van hertest, ...) door de gegenereerde gegevens te interpreteren en evalueren. Initieert en draagt ​​bij aan kwaliteitsevenementen, leidt referentiestandaardgerelateerde escalaties, voert impactbeoordelingen en risicobeoordelingen uit en definieert corrigerende maatregelen. Verantwoordelijk voor het bijhouden van de voorraad referentiestandaarden. Ondersteunt vragen uit interne en externe deponeringen. Neemt deel aan trainingen en initiatieven voor continue verbetering. Interpreteert de wettelijke richtlijnen voor kwaliteit en EHS en zorgt ervoor dat deze worden nageleefd. Zorg ervoor dat alle relevante regelgeving, GMP en veiligheid worden nageleefd.
jouw aanbod Masterdiploma in scheikunde, bio-ingenieur of farmaceutische wetenschappen, of gelijkwaardig door ervaring Bachelor minimaal 2 jaar ervaring met analytische technieken Diepgaande kennis en ervaring met analytische technieken die nodig zijn voor geneesmiddelen en aanverwante verbindingen. Sterke plannings- en volgvaardigheden, goed georganiseerd en in staat om meerdere projecten af ​​te handelen met betrekking tot prioriteiten en middelen Uitstekende organisatie, communicatieve vaardigheden in teamverband. Inzicht in wettelijke richtlijnen voor kwaliteit Flexibel en snel aan te passen aan de voortdurend veranderende zakelijke behoeften. Goede schriftelijke en mondelinge communicatieve vaardigheden in de Engelse en Nederlandse taal Praktische ervaring in de industrie en kennis van de GMP-regelgeving zijn een troef. · "Can do mentaliteit" en volledige verantwoordelijkheid nemen voor je werk
ons aanbod Deze functie kan je via Randstad Professionals invullen als consultant In ruil voor jouw prestaties en flexibiliteit bieden wij jou een salarispakket met enkele interessante extra's, zoals Bruto salaris volgens jouw ervaring Maaltijdcheques van € 7 per gewerkte dag Netto verloning van € 80,- per maand Bedrijfswagen met tankkaart (onder voorwaarden) of Kilometervergoeding Hospitalisatieverzekering 1 extra vakantiedag per gewerkte maand Eindejaarsbonus Pensioenplan ECO-vouchers ter waarde van € 250,- (op jaarbasis, pro rata) Trainingsmogelijkheden

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