Specialist II Pharmaceutical Quality Systems

Typical Accountabilities:
• Support specific quality system processes within assigned site / area.
• Assist in maintenance process governance structures within a site to ensure processes are properly documented, reviewed, and updated as necessary.
• Support analysis of process and data trends, and optimization of existing site processes.
• Provide guidance and support to cross-functional teams to address needs as related to own area (e.g. risk management, compliance, inspection readiness, investigation responses).
• Support oversight and management of learning management systems related to PQS within site / area.
• Collaborate with other quality systems colleagues to drive joint simplification and improvement work.
• Participate in audits, inspections, and response processes as applicable.
• Engage with cross-functional stakeholders within site for assistance in defense and responses, and share observations and learnings, as applicable.
• Support development / change and implementation of SOPs within area of responsibility.

Education, Qualifications, Skills and Experience

Essential:
• Entry level bachelor’s degree in science / engineering field suchas Pharmacy, Biology, or Chemistry.
• Experience with pharmaceutical manufacturingand quality.
• Strong orientation for continuous improvement and process streamlining and optimization.

Desirable:
• Some experience in business process / quality system management preferred.
• Experience applying Lean principles and supporting change initiatives within a structured framework preferred.
• Knowledge of / experience with newer digital tools
and technologies related to quality systems management preferred.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.