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Quality Assurance Officer
3 maanden geleden
Job Description
Ben jij een ervaren (Senior) Quality Assurance Officer met als specialisatie validatie?
Voor het Center of Excellence (CoE) Quality in Haarlem zijn wij op zoek naar een
(Senior) Quality Assurance Officer - Validatie
Over de functie
Als (Senior) Quality Assurance Officer ben je werkzaam binnen het validatie team van de afdeling Quality Assurance en draag je zorg voor controle op algemene cGMP compliance van onze productielocatie in Haarlem. Deze controles worden uitgevoerd op basis van interne guidelines, procedures, ervaring en interpretatie van algemene wet -en regelgeving. Als Quality Assurance Officer neem je deel aan multidisciplinaire projecten als vertegenwoordiger van Quality.
Welkom in ons team
De CoE Quality is verantwoordelijk voor het sturen en coördineren van het kwaliteitsbeleid van onze productielocatie in Haarlem, in overeenstemming met bestaande wet- en regelgeving. Hiertoe onderhouden de verschillende afdelingen contacten met alle Integrated Process Teams (IPT's) en Centers of Excellence (CoE's) van onze productielocatie in Haarlem en tevens met andere productiesites wereldwijd en het hoofdkantoor in de VS.
Primaire verantwoordelijkheden
Rapporterend aan de Manager QA ben je als (Senior) Quality Assurance Officer verantwoordelijk voor onder meer:
- Reviewen, adviseren en controleren van kwalificatie en validatie projecten binnen de site. Binnen deze projecten ben je de vertegenwoordiger van Quality.
- Het borgen van de gevalideerde status van cGxP processen en systemen.
- De Quality rol invullen bij technische projecten. Denk hierbij aan productie, verpakkingslijnen en labapparatuur.
- Ondersteunen en controleren op de afhandeling van deviaties.
- Controleren en autoriseren van GMP documenten, zoals SOP's, kwalificatie/validatie documentatie,, en change control documentatie.
- Ondersteunen van CoE's en IPT's bij het invoeren van wijzigingen in richtlijnen.
- Ondersteunen, reviewen en autoriseren van Quality Risk Assessments.
Jouw profiel
- HBO/BSc of WO/MSc diploma in een farmaceutische, proces-technische, life science of chemische richting, aangevuld met 3 jaar relevante werkervaring op het gebied van kwaliteit;
- Je hebt deze ervaring opgedaan in een vergelijkbare rol als QA Officer en hebt hierbij specifieke ervaring met kwalificaties, (cleaning)validaties;
- Je hebt ervaring met het werken onder GMP en/of GDP;
- Ervaring met verpakkingstechnologie, productietechnologie en labapparatuur is een pré;
- Overtuigingskracht en resultaatgericht;
- Nauwkeurig, flexibel en zelfstandig;
- Goede communicatieve vaardigheden in zowel woord als geschrift in de Nederlandse en Engelse taal.
Wij bieden
Werken bij ons betekent samen werken aan gezondheid in een internationale werkomgeving met toegewijde collega's.
Je krijgt alle ruimte om jezelf te ontwikkelen en te laten zien wie jij bent. Verder kan je rekenen op aantrekkelijke arbeidsvoorwaarden:
- Een competitief salaris;
- 35,5 vakantiedagen;
- 8% vakantietoeslag en 3% eindejaarsuitkering;
- Incentive Plan;
- Een uitstekend pensioen;
- Gratis gebruik sportschool;
- Reiskostenvergoeding;
- Verschillende trainingsmodules.
Current Employees apply HERE
Current Contingent Workers apply HERE
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
HybridShift:
Valid Driving License:
Hazardous Material(s):
Job Posting End Date:
07/23/2024*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Job Posting End Date:07/23/2024
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R299247
