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Quality Associate

Do you have proven working experience within the pharmaceutical industry and do you want to pursue a career in quality assurance (QA)? We are looking for enthusiastic applicants to help out in the documentation of the COVID-19 vaccine. If you have experience with quality assurance tasks within pharmaceutical industry and are looking for a new challenge, apply now!

Job description

Because of the COVID vaccine program there is an increased demand in the Clinical Immunology department. This department is responsible for the immunological evaluation of vaccine candidates in clinical trials. The department delivers data, which defines the immunological strategy supporting the clinical development. Therefore we are looking for a junior GCLP Quality Associate. The department is responsible for coordinating and performing clinical sample analysis in support of the clinical vaccine trials. In the position of documentalist you will be assisting with various QA-related tasks.

Responsibilities

  • Documentation of SOPs, ensure GCLP compliance;

  • Quality review and approval of the documents created in the document management system;

  • Deviation coordination for the GCLP facility, assist staff in writing deviations and review the deviations;

  • Provide assistance in the follow-up of audit findings;

  • Assigning proper training to the GCLP staff and review completeness of their training files;

  • Review and write validation- and software test protocols;

  • Review validation related documentation;


Profile

  • Bachelor of science + 2 years of relevant working experience in pharmaceutical industry;

  • Experience in interactions with quality assurance;

  • Experience in working with (GxP) quality systems;

  • Working experience with equipment and software validation;

  • Excellent verbal and written communication skills in English, able to review, edit and write quality related documents;

  • Hands-on experience with immunological assays is considered a pre;

  • Residence in the Netherlands and in possession of a valid working permit is a must;


Benefits

  • Employment: 10 months, contract via Oxford Global Resources;

  • Salary indication: from € 2000 to € 3000 gross monthly based on experience level;

  • Working hours: 32 to 40 hours per week;

  • Location: Leiden region

  • Vacancy number: 16567

Oxford Global Resources is het grootste recruitmentbureau binnen de vakgebieden Science, Engineering en IT. Al onze recruiters hebben zelf een relevante achtergrond binnen deze gebieden en helpen je graag bij het vinden van de perfecte baan in ons uitgebreide netwerk.

Als gespecialiseerde partij hebben wij een groot aanbod aan laboratorium vacatures op het gebied van Quality Control (QC) en Research &Development (R&D) binnen diverse sectoren, waaronder de Farmaceutische industrie, Biotechnologie, Contract Manufacturing, Contract Research, Voedingsmiddelenindustrie, Chemie, Milieu en Plantensector.

Oxford is altijd op zoek naar talent met expertise op het gebied van Biotechnologie, Immunologie, Biochemie, Virologie, Microbiologie, Moleculaire Biologie, Life Science, Analytische Chemie, Fysische Chemie, Polymeerchemie, Petrochemie en Diagnostiek. Wij komen graag in contact met kandidaten die ervaring hebben met een of meerdere van de volgende technieken: USP (Upstream Processing) DSP (Downstream Processing), Bioprocesses, viruskweek, celkweek, ELISA, FACS, Western Blot, SDS-page, PCR, RT-PCR, qPCR, kloneren, sequencing, eiwit zuivering, purificatie, HPLC, UPLC, chromatografie, fysische chemie, viscositeit, smeltpunt, pourpoint, pH, XRF, GC, GC-MS, LC, LC-MS, ICP ICP-MS, AAS, UV, titraties, Karl Fisher, formuleren, steriliteit, determinaties, bioburden, environmental monitoring, LIMS, GMP, GLP, GCP, GDP, ISO17025.

Vind je deze vacature interessant? Of ben jij op zoek naar een functie op MLO, HLO, BSc, WO, MSc of PhD en heb je interesse in de vacature laboratorium Assistent, Laborant, Laborant monstervoorbereiding, Analist, Technician, Assistant Scientist, Associate Scientist, Scientist, Manufacturing Specialist, Process Engineer, Validatie Engineer, QA (Quality Assurance) Officer, RA (Regulatory Affairs) Officer, Supervisor, Teamleider, Afdelingshoofd, Hoofd Laboratorium, Manager, Director, etc. Neem dan direct contact met ons op!