Quality Assurance Pharmacist
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 and FMCG organisation, based in Noord-Brabant Netherlands.
The semi-manufactured medicines are shipped to this site where the packaging is completed, labelled and distributed. The plant is fully GMP and GDP compliant.
- Perform risk analysis and impact assessments
- Review and approve production and Quality documentation
- Initiate, review and approve CAPA's, deviations, non-conformances and test protocols
- Support Quality investigations
- Change controls, GMP compliance checks
- Participate in internal and regulatory audits
- Support the development of GMP training materials for the plant and Quality employees
- Support of Validation activities
- Fulfill the requirements to become a Qualified Person
- +3 years of relevant Quality Assurance experience in a GMP, GDP environment
- Ability to work under limited supervision
- Proficient English skills
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
The Company
For a Pharmaceutical company with the distribution headquarters located in The Netherlands we are looking for a QA/QP Manager. From this site pharmaceutical products are delivered to all affiliates, hospitals and wholesalers in Europe, Middle East and North of Africa.The semi-manufactured medicines are shipped to this site where the packaging is completed, labelled and distributed. The plant is fully GMP and GDP compliant.
Role Description
The purpose of this role is the release of the medicinal products ensuring the full compliance of GMP regulations and marketing authorizations. Additionally, in this role you provide guidance to Production, Engineering and Quality.Responsibilities
- Participate in Global Quality Assurance projects- Perform risk analysis and impact assessments
- Review and approve production and Quality documentation
- Initiate, review and approve CAPA's, deviations, non-conformances and test protocols
- Support Quality investigations
- Change controls, GMP compliance checks
- Participate in internal and regulatory audits
- Support the development of GMP training materials for the plant and Quality employees
- Support of Validation activities
Requirements
- Master in Pharmacy (or related study that enables you to become a certified QP)- Fulfill the requirements to become a Qualified Person
- +3 years of relevant Quality Assurance experience in a GMP, GDP environment
- Ability to work under limited supervision
- Proficient English skills
Heb je interesse en wil je meer weten over deze functie, reageer dan door op solliciteer te klikken en contact op te nemen met Seppe Verhoeven
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