Incoming Quality Assurance (IQA), Part time, Breda

• Quality Assurance
• Netherlands, Breda
• Fulltime
• V-105401
• Competitive

Introduction:
The company is one of the world’s leading biotechnology companies, dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. Their mission is to serve patients, and they focus on areas of high unmet medical need, utilizing their expertise to strive for solutions that improve health outcomes and people’s lives. At their facility in Breda, they ensure that their medicines reliably reach the hands of patients around the world.
 
Accountabilities

• Ensure Inspected Drug Product (IDP) and Finished Drug Product (FDP) batches are ready for release by the Qualified Person (QP) and all procedural requirements for release have been met.
• Execute sampling, inspection, review and release of incoming materials.
• Review and approve minor deviations related to incoming quality assurance and warehouse activities.
• Perform reserve sample inspection in support of complaint and deviation investigations.
• Establish effective working relationships with warehouse, QA management and others outside area of expertise.

Responsibilities

• Sampling and Inspection of Inspected Drug Product (IDP) and Finished Drug Product (FDP), and review completed batch records ensuring all procedural requirements are met.
• Sampling, inspection, review and release of printed and non-printed packaging components.
• Review and approve minor deviations related to incoming quality assurance and warehouse activities.
• Review temperature data of shipments received.
• Additional sampling and Inspection of materials or drug products as needed.
• Perform damage inspection on received drug product and materials as needed.
• Perform reserve sample inspection in support of complaint and deviation investigations.
• Provide QA oversight for:
  • Issues upon receipt of components and product
  • Destruction Authorizations
  • Cancelled Ship Confirmed Orders
• Own training material and work instructions related to IQA processes.
• Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements.
• Collect data and initiate follow up with Amgen suppliers for receiving issue resolution in collaboration with the External Supply team.

Qualifications
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent:
Minimum Requirements

• MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience.
• Typically, 3 or more years of related experience or Master’s degree or equivalent.
• Fluent in English language.

Preferred Requirements
Experience with pharmaceutical industry

Competencies

• Logical and linear analytical skills to evaluate and interpret complex situations/problems using multiple sources of information.
• Understanding and application of principles, concepts, theories and standards of technical/scientific field.
• Keeps overview but also deep dives when appropriate.
• Effective communication skills at multiple levels and areas (inside and outside of Quality).
• Good attention to detail and sufficient technical writing skills.
• Good decision-making skills and ability to apply risk-based approach.
• Teamplayer, constructively working together towards solutions.

 What do we offer:

• 1 year contract for 24 hours
• Salary between € 4000 and € 4500 based on fulltime and on skills and knowledge
• 30 holiday days
• 8.33% holiday allowance