QC Analytical method validation
Location: BelgiumSIRE® 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 Brussels Hoofdstedelijk Gewest Belgium.
The laboratory also specializes in supporting the generation of the data required for the registration dossiers of our new products (determination of the degradation profile, determination of the stability of the product under normal / stressed conditions, etc.).
- Verifies, transfers and validates the analytical methods according to the appropriate requirements
- Actively participates in stability studies of pharmaceutical products developed in R&D
- Actively participate in pharmaceutical product development studies carried out in R&D (formulation development, freeze-drying cycles, development of manufacturing processes, etc.)
- Ensures all activities related to other types of studies in place at the QC laboratory in R&D
- Ensures complete follow-up of the studies under its responsibility in accordance with applicable procedures
- Experience in the pharmaceutical industry, preferably in an analytical or development laboratory, is desired.
- Analytical Chemistry Oriented.
- Good knowledge of analytical techniques (UV / (U)HPLC, GC, etc.) is required. Knowledge of the principles of validation of analytical methods as well as pharmacopoeias is an asset.
- Knowledge of GMP as well as the quality system of the Pharmaceutical Industry is desirable.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
The Company
The laboratory specializes in the development, validation and transfer of analytical methods for all products entering the site.The laboratory also specializes in supporting the generation of the data required for the registration dossiers of our new products (determination of the degradation profile, determination of the stability of the product under normal / stressed conditions, etc.).
Role Description
The function of analytical specialist involves the generation of data in the laboratory for the development and validation of new analytical methods and the monitoring of product stability studies.Responsibilities
- Develops analytical methods in accordance with the specifications- Verifies, transfers and validates the analytical methods according to the appropriate requirements
- Actively participates in stability studies of pharmaceutical products developed in R&D
- Actively participate in pharmaceutical product development studies carried out in R&D (formulation development, freeze-drying cycles, development of manufacturing processes, etc.)
- Ensures all activities related to other types of studies in place at the QC laboratory in R&D
- Ensures complete follow-up of the studies under its responsibility in accordance with applicable procedures
Requirements
- MSc / engineer with scientific orientation- Experience in the pharmaceutical industry, preferably in an analytical or development laboratory, is desired.
- Analytical Chemistry Oriented.
- Good knowledge of analytical techniques (UV / (U)HPLC, GC, etc.) is required. Knowledge of the principles of validation of analytical methods as well as pharmacopoeias is an asset.
- Knowledge of GMP as well as the quality system of the Pharmaceutical Industry is desirable.
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
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