QA Specialist Suppliers

Location: Netherlands

SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

THE COMPANY

Our client is a professional Pharmaceutical organization, based in Zuid-Holland Netherlands.

A multinational company that belongs to the top of the pharmaceutical industrie.

ROLE DESCRIPTION

Quality and Compliance support for the quality manager, supporting functions and activities including Quality assurance review and preparation functions (such as Change Control, Validation), Compliance audit activities, due diligence assessments, supporting creation and management of supplier development plans and organizational structures. Supports Quality Manager in ensuring business, quality and compliance goals adhere to the organization and government-issued environmental, health, safety, quality and regulatory policies and guidelines. Represents the companies credo and quality values in contact with the third-party manufacturers and will comply with the companies regulations for ethic and business conduct in order to strengthen the reputation of the organization.

RESPONSIBILITIES

- Supporting the planning, execution, and documentation of the qualification and monitoring for third party suppliers who are delivering excipients,
raw or packaging materials, to the companies Supply Chain for the manufacture of Intermediates, APIs, or drug products respectively
- Supporting surveillance on the quality and compliance status for all third party supplied raw materials, packaging materials, intermediates,
excipients, and APIs.
- Management of Change in Trackwise (change assessor, action executioner)
- Assessment of deviations, corrective and preventative actions (CAPAs), and complaints concerning suppliers.
- Supporting execution of establishment and periodic review of Quality Agreements
- Supporting establishment and revision of Qualification Statements, quarterly performance metrics, and annual qualification classification for
suppliers
- Support API manufacturers during health authority inspections
- Supporting activities related to Initial assessment and qualification of suppliers for new product introductions
- This position requires the ability of building collaboration and teamwork across the local and global organization
- Support Quality processes within the API manufacturing site in relation to external suppliers
- Support internal site Regulatory inspections
The task profile comprises but is not limited to:
- Management of Change in Trackwise (change assessor, action executioner, )
- Supporting ESIQ-SQ contact point for the API sites in the EMEA
- Supporting all activities of SQ Quality Manager

REQUIREMENTS

- HBO/Bachelor
- Minimal 2 years of experience in quality management, production, quality control, or R&D in a pharmaceutical and/or biotechnology environment with
experience in external manufacturing operations or Quality Assurance for external manufacturing
- Exposure to regulatory authorities inspections
- Deep understanding of Quality processes and systems
- Strong plus: experience with Trackwise software

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