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Sona***********
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Spain
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Last Update: 11.06.2019 at 10:08
Job Type
Full Time
Start
Jun , 2019
Duration
6 Month
Place
Azuqueca de Henares, Castilla-La Mancha, España
Country
Spain
Category
Description
Job description Global Responsibility: Under the responsibility of the R&D Pharmaceutical Development Team Leader Injectables, the Pharmaceutical Development Technician will have the fallowing functions: Proactively execute the experimental activities required during the formulation and process development of injectable drug products of different pharmaceutical sterile farms varying from aqueous & oily solutions, suspensions, lyophilized and depot formulations. Generate test data to characterize trial formulations and execute pre-formulation, formulation and process development trials according to GMP requirements. Write protocols and reports with results obtained in the analysis performed. Actively participate to the set up the pharmaceutical development laboratories, contribute to the instruments purchasing and support their installation, qualification ad maintenance. Write laboratory SOPs. Support the interaction with raw material vendors to contribute to the selection of the suitable quality far API, excipients, container closure systems and consumables (e.g. filters) to be used for development and manufacturing. Be responsible for the routine tasks of the laboratory: managing of reference standards, reagents, orders, (daily) verification of equipment (analytical balance, pHmeter, etc…), cleaning activities, stock controlling and so on. Specific Responsibilities: Perform routine testing related to compendial monographs and general chapters: IR/UV analysis, Assays, pH measurement, viscosity, density, colour etc. Perform measurements, computations, tabulation, and analyse results related to the testing conducted. Under the supervision of more experienced analysts, perform basic non-routine instrumental analysis. Operate and maintain/calibrate laboratory equipment as per manufacturer’s recommendations and company’s Preventive Maintenance program. Maintain laboratory records related to all testing activities assuring that they are accurate and up to date. Perform other related duties as assigned. Perform all analysis and lab related duties as per cGMP. Work on the development and validation of robust characterization methods for the testing of pharmaceutical products, according to Good Manufacturing Practices (cGMP) and ICH guidelines. Write method development and validation protocols of galenic characterization methods and reports of the generated data in a critical way. Write methods and Standard Operating Procedures under the supervision of the more senior members. Provide experimental support to the rest of the team and other departments. Complete OOS and Deviations documentation assigned. Collaborate during the transfer of analytical methods to QC labs, and during process tech transfer at manufacturing scale. Ensure good relationships and collaboration with all other teams in formulation development, QC, operations, QA, etc. Requirements: Education: Bachelor or Degree in Pharmacy, Chemistry or related scientific degree. Languages: good level of spoken English and very good level in written communication. Spanish fluency is mandatory. Experience (years/area): Minimum 1-year experience in pharmaceutical industry and GMP environment is required. Experience in Pharmaceutical Development of sterile formulations (injectables, ophthalmic, etc.) is an asset, as well as knowledge of statistical analysis and galenic methods development Travels: Ability to travel domestic (occasionally) Personal skills: Proactivity, creativity with good problem-solving skills. Demonstrated ability to communicate and effectively interact with cross functional teams and outside teams.