Quality Assurance Advisor

Pharmaceutical Development's Quality Assurance (QA) function is recruiting QA Advisors with a Good Manufacturing Practice (GMP) focus for six months temporary contracts. The QA Advisor role has a broad range of responsibilities to ensure that activities and processes in Pharmaceutical Development functions and the R&D supply chain comply with Regulatory requirements, Good Manufacturing Practices and AZ internal quality system requirements.

Interactions occur among various internal functions and sites, but also with vendors and suppliers. The role can be based at either Mölndal in Sweden or Macclesfield in UK.

- Provide QA input into Pharmaceutical Development internal/external manufacturing activities for Drug Substance and Drug Product, the approval of manufacturing documentation
- QA release of internally/externally manufactured and packed Drug Substance and Drug product as part of the Supply Chain to clinical trials.
- Support the Pharmaceutical Development functions with investigations of deviations and other quality and compliance decisions having a major impact on AstraZeneca development projects.
- Provide Pharmaceutical Development projects' with QA support, such as GMP risk assessment and interpretation of GMP regulations
- Provide appropriate QA input to business improvement projects
- Close collaboration with AstraZeneca QA colleagues globally.

MINIMUM REQUIREMENTS -EDUCATION AND EXPERIENCE

- Scientific degree with at least 3 years experience of working within a pharmaceutical GMP environment,
- Broad understanding of Quality Systems and GMP
- Comprehensive understanding of the pharmaceutical/drug development process
- Good communicator with experience of interacting effectively across interfaces
- Fluent in written and spoken English

PREFERRED EXPERIENCE/REQUIREMENTS

- Experience preferably within a pharmaceutical development organisation
- Good team working and networking skills
- Capable of making effective decisions
- Demonstrate a high degree of personal credibility

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