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Senior Analytical Development Specialist (Respiratory)
Firma: Adamed Pharma S.A. miejsce pracy: Pabianice
Senior Analytical Development Specialist (Respiratory)
Location: Pabianice
Tasks:
- Development, validation and implementation of new analytical methods in accordance with the current EU and FDA requirements,
- Development of analytical documentation necessary to perform pilot production - specification, analytical instructions and performing analyzes during this production, as well as during stability tests,
- Designingn, planing, performing, interpreting and reporting results of analytical experiments for the preparation and timely delivery of inhalation drug product,
- Development of analytical methods, validation, release and stability analysis in compliance with GxP standards and regulatory requirements,
- Generates regulatory documents and internal documents for quality control, operations instructions and reports.
Requirements
- Minimum five years of experience in analytical methods development of inhalation drug product in pharmaceutical industry,
- Strong knowledge of relevant GLP and GMP regulations and policies are desirable,
- Knowledge of registration procedure and Dossier Registration eCTD (Module 3) creation,
- A thorough knowledge of state-of-the-art analytical instrumentation/equipment for broad field of applications, mainly connected with inhalation drug product development eg. DUSA, NGI,
- Strong experience in HPLC / UHPLC methods development,
- Good knowledge of MS Office software and knowledge of Empower software,
- Higher education (pharmacy, chemistry, etc.),
- Very good commad of English.
We offer
- A chcance to join newly created R&D Respiratory Team,
- Access to state of art technologies and cooperation with international partners,
- Full impact on scope of performed work on project,
- Very good remuneration (base and bonus),
- Benefits (private medical, insurance and others).
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Data dodania: 03-08-2021
Wyświetleń: 254
Wyświetleń: 254