Associate QA Complaints
Noord-Brabant, The Netherlands
1 dag geleden

The company

Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands. This international company is leading in the field of human medicines in the biotechnology industry.

The department in Breda has a challenging and interesting position for a Sr. Associate QA Complaints.

Role description

Complaints handling (including performing assessments) in accordance with internal procedures, regulatory guidelines and business performance objectives.

Problem Solving

  • Applies research, information gathering, analytical and interpretation skills to problems of diverse scope;
  • Ensures compliance within regulatory environment;
  • Develops solutions to technical problems of moderate complexity;
  • Screens, categorizes, evaluates, reconciles, reports and resolves data integrity issues;
  • Interprets generally defined practices and methods;
  • Autonomy

  • Works under general direction;
  • Work is guided by objectives of the department or assignment;
  • Refers to technical standards, principles, theories and precedents as needed;
  • May set project timeframes and priorities based on project objectives and ongoing assignments;
  • Recognizes and escalates problems;
  • Contribution

  • Contributes to work group / team by ensuring the quality of the tasks / services provided by self;
  • Contributes to the completion of milestones associated with specific projects or activities within own department or workgroup;
  • Provides training / guidance to others and acts as a technical / scientific resource within work group / team;
  • Establishes working relationships with others outside area of expertise;
  • Position Specific Tasks

  • Initiate and own product quality complaints, Safety quality investigations and product security investigations for Amgen commercial and / or clinical products;
  • Perform assessments in support of complaint investigations (e.g. batch record review, reserve sample inspection, Return sample inspection and Safety Features verification);
  • Partner with corporate product quality surveillance, assessors from other Amgen sites and contracted partners to resolve product complaint investigations;
  • Partner with Amgen affiliates in country and intake call centers on call intake procedures and complaint investigations;
  • Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements;
  • Assist in Amgen Breda projects and improvement efforts as needed;
  • Provide training to ABR and Amgen affiliate staff on complaint handling procedures and performing investigations / assessments;
  • Initiate and own QA Non Conformances / CAPAs as needed;
  • Participate in site regulatory inspections of complaint handling process and in audits (internal and third party) as required;
  • Minimum Requirements

    MBO or Bachelor’s degree or equivalent

  • Typically 3 or more years of related professional experience;
  • Fluent in English language;
  • Master’s degree or equivalent;
  • Minimal related professional experience;
  • Fluent in English language;
  • Preferred Requirements

  • Experience in Quality Assurance, including handling product complaints investigations;
  • Experience in pharmaceutical industry;
  • Understanding and application of principles, concepts, theories and standards of technical / scientific field;
  • Specialized knowledge within own specialty are;
  • Deepens technical knowledge through exposure and continuous learning;
  • Knowledge of related regulatory / industry considerations, compliance issues and / or scientific discovery;
  • Other information

    Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Rutger Koning.

    Bij de favorieten invoegen
    Verwijder van favorieten
    Mijn E-mail
    Door op "voortzetten" te klikken, gaat u ermee akkoord dat neuvoo uw persoonlijke gegevens verzamelt en verwerkt die u in dit formulier hebt verstrekt, om een ​​neuvoo-account te maken en u te abonneren op onze e-mailwaarschuwingen, in overeenstemming met ons Privacybeleid . U kunt uw toestemming te allen tijde intrekken door te volgen deze stappen .