QA Specialist
Location: NetherlandsSIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands.
- Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
- Follow-up on corrective actions derived from investigations through completion.
- On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
- Communication and escalation of complaints, site representation on the product complaint network
- MSc. or BSc. in the Life Sciences;
- Minimum of 2 years of working experience related to the function;
- Strong project management skills;
- Team-oriented, matrix environment and work effectively with diverse departmental groups
- Customer service skills to operate and deliver results in a matrix-managed GMP environment.
- Computer literacy, independently understand
The Company
A leading biotechnology companies who's mission is to discover and innovate medicines for patients with serious illnesses.Role Description
Supporting the product complaint system at Amgen through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner.Responsibilities
- Update the complaints database as soon as factual information is available and summarize closed investigations into the database accurately.- Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
- Follow-up on corrective actions derived from investigations through completion.
- On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation.
- Communication and escalation of complaints, site representation on the product complaint network
Requirements
- Excellent writing skills to minimize the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers;- MSc. or BSc. in the Life Sciences;
- Minimum of 2 years of working experience related to the function;
- Strong project management skills;
- Team-oriented, matrix environment and work effectively with diverse departmental groups
- Customer service skills to operate and deliver results in a matrix-managed GMP environment.
- Computer literacy, independently understand
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