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Analytical Quality & Compliance Specialist

Analytical Quality & Compliance Specialist

Pharmaceutique / Biotechnologies / Chimie
  • Temporaire - Temps plein
  • Référence : INT-018768
  • Partager:

Détails

  • Région Neuchâtel
  • Type de contrat Temporaire - Temps plein
  • Secteur d'activité Pharmaceutique / Biotechnologies / Chimie

Introduction

On behalf of our client, a reconised company based in Neuchâtel, we are currently looking for a

Analytical Quality & Compliance Specialist

 

Description de la mission

The AQ&C Specialist will focus on Quality Assurace (QA) review and approval of technical documents pertaining to GMP analytical methods for small molecules drug substances and drug products.  The scope of documents will range from early clinical development through registration and commerical lifecycle of methods.  Specific technical document types include analytical method prodedures, method validation protocols and reports, method transfer protcools and reports, reference standard and critical reagent qualifiation protocols and reports, certificates of analysis, analytical change controls and general procedural documents.  This QA role will also partner with analytical functional areas to resolve associated deviations and other exceptional conditions, and assist with CAPA identification and resolution.

Perfrom the QA review/approval of technical documentation, including but not limited to:

Analytical method validation protocols and reports for in process, release, and stability testing

Analytical method procedures and associated change controls

Method technical transfer protocols and reports

Reference material and critical reagents qualification protocols and reports

Standard Operation Procedures and other controlled document

Collaborate with clinical or commerical analytical functions to determine the appropriate resoutions or CAPAs for protocol deviations and exceptional conditions related to validation or technical tansfer of analytical methods or qualification of reference material and critical reagents

Communicate, share and escalate issues within team for consensus resolution

Assist in the development of procedural and other guidance documents for Quality and QC functions



    Profil attendu

    Minimum B.A. or B.Sc. in life sciences

    Minimum of 5 years professional experience in Biologics Quality Assurance, Quality Control, analytical chemistry, method development is desirable
    Previous experience in QC laboratory facing QA activities is highly desirable
    Previous experience using electronic document and deviation management systems (i.e. DCA, Infinity, PDLIMS, Trackwise) is desirable.
    Experience and/or knowledge of QC biologics testing
    Working knowledge of GMP environment is desirable


    Working knoweldge of QC, QA, analytical method

    development or method validation functions

    Understanding and knowledge of FDA guidelines and

    GxP regulations.

    Excellent communication, attention to detail, relationship management, negotiation,

    problem-solving and personal time management skills

     Ability to manage multiple priorities with aggressive timelines


    Informations

    • Agence INTERIMA - LA CHAUX DE FONDS
    • Publié le 22 juillet 2021
    • ConsultantAnne-Claude ATTARD