Associate QA Complaints
SIRE
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.

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