Candidatul Ideal
Experience with analytical instrumentation commonly used in E&L, N-Nitrosamines or Elemental Impurities studies.
studii: Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field
Foreign languages: English
Min. 1 year of experience with analytical instrumentation commonly used in E&L, N-Nitrosamines or Elemental Impurities studies.
Hands-on experience operating chromatographic and spectrometric instrumentation.
Strong understanding of analytical chemistry principles.
Experience working in a GMP/GLP laboratory environment (preferred).
Familiarity with extractables and leachables methodologies is an advantage.
Solid mathematical and data-processing skills.
studii: Bachelor’s or Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field
Foreign languages: English
Min. 1 year of experience with analytical instrumentation commonly used in E&L, N-Nitrosamines or Elemental Impurities studies.
Hands-on experience operating chromatographic and spectrometric instrumentation.
Strong understanding of analytical chemistry principles.
Experience working in a GMP/GLP laboratory environment (preferred).
Familiarity with extractables and leachables methodologies is an advantage.
Solid mathematical and data-processing skills.
Descrierea jobului
The E&L Specialist is responsible for designing, executing, and reviewing scientific studies that assess the safety of materials used in pharmaceutical products, medical devices, and packaging systems. This role ensures compliance with regulatory expectations, supports product development, and contributes to risk assessments by providing high‑quality analytical data on extractables and leachables, N-Nitrosamines or Elemental Impurities.
Key Responsibilities:
Develop and execute Extractables and Leachables studies for raw materials, packaging components, single-use systems, and drug products.
Design study protocols based on regulatory guidelines (USP, ISO, EMA, FDA) and product-specific risk assessments.
Perform analytical testing using techniques such as GC-MS, LC-MS, ICP-MS, and headspace analysis.
Interpret analytical data, identify unknown compounds, and provide toxicological relevance in collaboration with toxicology experts.
Prepare and review technical reports, study protocols, and regulatory submission documents.
Support investigations related to material compatibility and potential product contamination.
Collaborate with Quality, R&D, Manufacturing, and Regulatory Affairs teams to ensure compliant and timely study execution.
Maintain up-to‑date knowledge of industry trends, regulatory updates, and best practices in E&L testing.
Ensure laboratory practices meet GMP, GLP, and internal quality standards.Key Competencies:
Analytical thinking and attention to detail.
Technical expertise in chromatography and mass spectrometry.
Strong communication and technical writing skills.
Ability to work collaboratively.
Project and time management.
Key Responsibilities:
Develop and execute Extractables and Leachables studies for raw materials, packaging components, single-use systems, and drug products.
Design study protocols based on regulatory guidelines (USP, ISO, EMA, FDA) and product-specific risk assessments.
Perform analytical testing using techniques such as GC-MS, LC-MS, ICP-MS, and headspace analysis.
Interpret analytical data, identify unknown compounds, and provide toxicological relevance in collaboration with toxicology experts.
Prepare and review technical reports, study protocols, and regulatory submission documents.
Support investigations related to material compatibility and potential product contamination.
Collaborate with Quality, R&D, Manufacturing, and Regulatory Affairs teams to ensure compliant and timely study execution.
Maintain up-to‑date knowledge of industry trends, regulatory updates, and best practices in E&L testing.
Ensure laboratory practices meet GMP, GLP, and internal quality standards.Key Competencies:
Analytical thinking and attention to detail.
Technical expertise in chromatography and mass spectrometry.
Strong communication and technical writing skills.
Ability to work collaboratively.
Project and time management.
Descrierea companiei
Infomed Fluids este o companie romaneasca specializata in fabricarea si comercializarea produselor farmaceutice destinate terapiilor parenterale si medicinei de urgenta. Infomed Fluids este o subsidiara a ACS DOBFAR INFO (Elvetia), renumita filiala a ACS DOBFAR HOLDING, care de peste 30 de ani ocupa un loc important pe piata mondiala in producerea de antibiotice de tip penicilina si cefalosporine.
Astazi Infomed Fluids este prezenta pe diferite piete europene cu obiective ambitioase si cu produse de maxima calitate.
Astazi Infomed Fluids este prezenta pe diferite piete europene cu obiective ambitioase si cu produse de maxima calitate.
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