Tuesday , February 27 2024

Astra Zeneca Jobs – Stability Quality Assurance Manager

Website AstraZeneca

Job Description:

The Global Stability Management (GSM) Team sits within Global Quality Control & Stability. The team manages and provides stability expertise for technical issues. The group designs and manages an optimised global stability programme to monitor and ensure the quality of our products throughout their shelf life. The team acts globally and support all product licenses in all markets. The group operates in the interface between the operation sites, stability testing sites and the regulatory function. It has prime accountability for proactive and focused support on all aspects of stability management for all global operations sites. The team has a regulatory and technical focus.

Job Responsibilities:

  • You will be responsible for assuring that a commercial product portfolio is managed in compliance with AstraZeneca’s commercial stability obligations.
  • You will use your expertise to analyse stability information and data to support license management for global products.
  • You will also need skills to influence stakeholders and project team members.
  • Your role will involve the strategic and technical assessment of supply chain changes, process and packaging changes, and translating findings into the appropriate programmes of stability studies.
  • The Stability Quality Assurance Manager will be responsible for overall surveillance of data, stability profiles and issues arising from the global commercial stability program.
  • Driving investigations that will involve multiple functions from the supply chain of affected products and assure the integrity of stability study reports intended for submission to regulatory agencies.
  • You will also be required to identify issues that may lead to non-compliance with GMP, regulatory requirements and commitments, and advise on areas for improvement across Global Stability Management.

Job Requirements:

  • Strong data handling skills and an understanding of the importance of data integrity
  • Educated to Degree or Equivalent experience in a science discipline
  • Experience in Regulatory, QA/QC or pharmaceutical development in a Pharmaceutical or related Industry

Job Details:

Company: AstraZeneca

Vacancy Type: Full Time

Job Location: Macclesfield, England, UK

Application Deadline: N/A

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