Senior Auditor

4 days ago

Macclesfield, United Kingdom AstraZeneca Full time

AstraZeneca is a global, science-driven biopharmaceutical company with a pipeline of exciting new medicines with an array of modalities. We are dedicated to discovering, developing, and delivering innovative, meaningful medicines and healthcare solutions that enrich the lives of patients.

At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult Situations because we are committed to doing the right thing.

As a Senior Auditor, you will be responsible for audits, of AstraZeneca manufacturing sites, contractors, due diligence and internal audits where a higher level of skills and experience is required. Audits are conducted following local and international regulations/guidelines and company quality standards to assure compliance with cGMPs. The senior auditor possesses advanced audit skills and specialised knowledge in one or more different areas e.g. sterile manufacture, API ́s, excipients and packaging etc. The audits focus on all clinical phase of development.

**What you’ll do**:
Performs complex and demanding domestic, regional and international audits of suppliers of chemicals, packaging components, and finished drug products, or contracted services
- Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings
- Initiate and maintain close contacts with regulatory agencies and/or industry/professional organizations to keep aware of trends and initiatives in quality assurance, GMP compliance, and inspections
- Work closely with other QA colleagues to assure common understanding of developing interpretations of cGMP

**General accountabilities**:

- Build and maintain strong customer relationships with other functions whose activities overlap, influence or affect compliance and lead or participate in GxP audits/initiatives with other AZ quality groups
- Develop solutions to a diverse range of problems that require complex judgements, using highly developed levels of conceptual thought and analysis
- Drives, role models and supports a strong lean culture that promotes standardisation, simplification and continuous improvement

**Essential Requirements**:

- Appropriate scientific degree with extensive experience and with a reputation of working within a pharmaceutical GMP environment, preferably within a pharmaceutical development organisation
- Solid knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance teams
- Ability to travel extensively (up to 60% of time local/regionally/global)

There are so many fantastic employee benefits that AstraZeneca offer AstraZeneca can offer you a competitive salary, private healthcare, a fantastic holiday allowance, phenomenal training and development opportunities, and much more.

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