SIRE Life Sciences®

QA Associate

Location: Netherlands
Our clients shared mission—to serve patients—drives all that we do. It is key to becoming one of the world’s leading biotechnology companies. They are global collaborators who achieve together—researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It’s time for a career you can be proud of.

- Understanding and application of principles, concepts, theories and standards of technical/scientific field
- 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
- Refers to technical standards, principles, theories and precedents as needed
- Recognizes and escalates problems
- Contributes to work group/team by ensuring the quality of the tasks/services provided by self
- Approve class 1 deviations related to IQA and WH related activities.
- Perform complaint assessments at the company in accordance with internal procedures, regulatory guidelines and business performance objectives.

More Responsibilities:
- Initiate and own Minor deviations related to IQA/WH/Complaints Lab activities.
- Provide QA oversight for Regulatory labelling in the WH
- Destruction Authorizations
- Own training material related to IQA processes..
- Perform assessments in support of complaint investigations (e.g. Reserve sample inspection, Return sample inspection and Safety Features verification)
- Prepare, review and approve procedures or work instructions in compliance with corporate, site and regulatory requirements
- Assist in projects and improvement efforts as needed
- Participate in site regulatory inspections of complaint sample handling process and in audits (internal and third party) as required.

- Bachelor's degree in Life Sciences or related field or the equivalent combination of education and/or experience.
- 0 - 1 year of related experience.
- Experience in Quality Assurance in pharmaceutical industry
- Fluent in Dutch and English language.

Interested? Do you see yourself in this role. Then do not hesitate to click on this apply button.
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SIRE Life Sciences®

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