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Occupational Toxicologist to AstraZeneca

Poolia Life Science Stockholm

We are looking for candidates to a consulting assignment as an Occupational Toxicologist to our customer AstraZeneca. As an Occupational Toxicologist you will be providing expertise for health hazard and risk assessment, primarily occupational and product quality-related toxicology, within Global Safety, Health and Environment for AstraZeneca. Location for this role will be Södertälje, Gothenburg or Cambridge, UK. Do you have an advanced degree in toxicology, pharmacology, industrial/occupational health or related biomedical science field and experience in hazard/risk assessment within pharmaceuticals and/or bio-pharmaceuticals industry? Please don't hesitate and send in your application already today. Welcome to Poolia Life Science!

The role

Global Safety, Health and Environment (SHE) exists to help AstraZeneca protect our people and the planet. We drive improvement in SHE performance, maintain compliance and otherwise protect the company's reputation. We do this by setting strategy and providing specific SHE expertise or accessing it through the wider SHE network.
We lead our industry in our development of a strong and varied pipeline. This means our people are here to win, we give you a breadth of opportunities to be curious and do cutting edge, unique work that has big impact on science and medicine.

Working on a strong pipeline means so much more than producing innovative, groundbreaking medicines. It allows AstraZeneca people to be part of long-term development programs with the variety that comes from working at the leading edge of science and technology.

As an Occupational Toxicologist or Health Hazard Assessment Specialist, you will be providing expertise for health hazard and risk assessment (primarily occupational and product quality-related toxicology) within Global Safety, Health and Environment (GSHE) for AstraZeneca and the AstraZeneca Group.

Key responsibilities
  • Provide robust, scientifically-sound risk management processes to support health hazard assessment for: employees handling proprietary and non-proprietary chemicals used in the production of medicinal products in the workplace, environmental toxicology and product quality activities (primarily associated with manufacturing).
  • Update and revise AZ procedures and guidelines related to health hazard assessment. Revise and/or develop hazard banding or default methodologies for early stage projects in lieu of established health-based exposure limits (HBELs).
  • Establish HBELs and author documentation for regulatory compliance, including Permitted Daily Exposures (PDEs) to support of product quality (e.g. cleaning validation, impurities and product excursions and worker health and safety activities (e.g. occupational exposure bands and limits (OEBs and OELs)).
  • Provide toxicological risk assessments for project teams and development and regulatory/project toxicology leads
  • Impurities, intermediates and degradants
  • Extractables and leachables
  • Excipients
  • Quality excursions (i.e. contaminants, extraneous matter)
  • Provide expert technical advice and prepare toxicology assessments in support of health hazard classification:
  • Safety Data Sheets according to GHS and CLP, and Dangerous Goods
  • Chemical notification/registration (i.e., EU REACH, China REACH, etc.)
  • Provide technical and scientific support for Environmental Reference Concentrations and Maximum Tolerable Concentrations.
  • Collaborate with industrial hygiene network, operations, R&D and engineering as part of comprehensive occupational hazard evaluation, controls and risk assessment.
Essential skills
  • Advanced degree in toxicology, pharmacology, industrial/occupational health or related biomedical science field.
  • Experience in hazard/risk assessment within pharmaceuticals and/or bio-pharmaceuticals industry.
  • Proven proficiency in technical science writing, specifically regarding chemical monographs for risk assessment.
  • Experience in toxicology assessments for both occupational (e.g. worker exposure) and product quality (e.g., patient safety).
  • Fluency in relevant international regulations and guidelines for both worker and product safety (EMA, FDA, ICH, ISO, USP, OSHA, COSH, etc.).
* Excellent written and verbal communication skills as well as proven negotiation, collaboration and interpersonal leadership skills.

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52 dagar sedan

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