Senior QA Associate CMO

Bedrijfsnaam: -
Plaatsingsdatum: 17/09/2018
Standplaats: -


SIRE® 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 Zuid-Holland Netherlands.The CompanyThey bring ideas, products and services to life to advance the health and well-being of people around the world. they believe in helping people everywhere live longer, healthier, happier lives.

Role DescriptionThe Senior QA Associate CMO provides Quality support for late stage development projects. He/she will be responsible for QA oversight, including leading GMP audits at contract manufacturers and QA review/approve validation documentation. He/she enforces quality requirements, establishes Quality systems for new technologies, reviews development data, approves Quality documentation and supports activities related to regulatory submissions and inspections.

Responsibilities- Serves as a dedicated Quality representative on project teams responsible for development of vaccines drug products.
- Responsible for Quality oversight of contract manufacturers
- Focuses on technical issues relative to interpretation of policies, compliance and current industry standard.
- Maintains and interprets KPI’s and advices measures to improve.
- Effective stake holder management. Primary contact person for internal departments, external (global) departments and contract manufacturers.
- Challenges the status-quo. Involved in conception of new ideas with respect to production and technical quality processes and output as data for decision making

Requirements- Independent and organized accurate worker, with eye for detail and good writing skills
- Understands Quality requirements in dynamic environment and able to think and challenge beyond own expertise area, has a strategic (Quality) vision
- Demonstrates ownership in proactively identification of issues, has problem-solving capabilities, and timely implements solutions.

Specific professional/technical requirements:
• Education: Minimally MSc in a relevant discipline, like biomedical sciences, (medical) biology or life sciences
• Experience: Requires (6-8) years QA experience, vaccines technology experience and fill finish
• Other: Pro-active, agile, and enjoys working in a team.

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.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
5 - 10 jaar
Contactgegevens :