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Oferta pracy: Senior Analytical Specialist (Respiratory)

Senior Analytical Specialist (Respiratory)
Location: Pabianice
Responsibilities
  • Involvement in inhalation projects, study of drug substances and dosage forms, starting from early development through to transfer to pharmaceutical production in the scope of:
  • development, validation and implementation of new analytical methods, release and stability analysis in accordance with GxP standards and current regulatory requirements (EU, FDA),
  • development of analytical documentation necessary to perform pilot production - Specification, Analytical Instructions and performing analyzes during this production, as well as during stability tests"
  • Main responsibilities are to design, plan, perform, interpret and report results of analytical experiments for the preparation and timely delivery of inhalation drug product
  • Strong knowledge of relevant GLP and GMP regulations and policies are desirable
  • Experience in using a variety of instrumentation techniques e.g. DUSA, NGI and other applicable analytical instruments: PSD, UHPLC, KF Highly communication and presentation skills; evaluates data and contributes in problem solving
  • Generates regulatory documents and internal documents for quality control, operations instructions and reports
Requirements
  • Minimum 5 years of directly related experience as analytical senior specialist (including inhalation drug products) in pharmaceutical industry
  • Good knowledge of MS Office software and knowledge of Empower software is prerequisite
  • Strong knowledge of relevant GLP and GMP regulations and policies is desirable. Knowledge of registration procedure and Dossier Registration eCTD (Module 3) creation thorough knowledge of state-of-the-art analytical instrumentation/equipment for broad field of applications, mainly connected with inhalation drug product development e.g. DUSA, NGI
  • Experience in the analytics of inhalation dosage forms is advantageous
  • A track record in HPLC / UHPLC method development
We offer
  • Full time contract of employment
  • Private medical care for a co-worker and family (rehabilitation without limits, treatment option for a dental and Senior package on preferential terms)
  • Relocation package
  • Co-financing of Allianz group insurance, option for a spouse/partner
  • Health package for 5 (cyclical flu vaccinations, cafeteria of preventive examinations, state prevention campaign, COVID tests, mental health support)
  • Benefits from the Social Benefits Fund (points in the benefits cafeteria)
  • jubilee awards
  • Employee recommendation program (the possibility of using financial bonuses for recommending people to work)
  • Company events, e.g. Festival of Values, Festival of Science
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