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AstraZeneca
,
Macclesfield, Cheshire
Senior Auditor
Overview
Job Description
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. Our Development Quality team ensures the delivery of safe, effective and compliant medicines to patients participating in global clinical studies. We set standards and apply scientific and Quality expertise to our exciting drug pharmaceutical development portfolio and help maintain our reputation and license to operate. We also play an important part in the commercialisation of new medicines, working closely with our colleagues in Operations. Development Quality is a Global group, with teams located in Macclesfield, (UK), Gothenburg (Sweden), Durham (North Carolina, US), Gaithersburg (US), Redwood City (US) and Bad Homburg (Germany). We are now looking for a Senior Auditor to strengthen our Development Quality team! As a Senior Auditor, you are 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, APIs, excipients and packaging etc. The audits focus on all clinical phase of development. Main duties and responsibilities 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 Proven ability to continually refresh cGMP interpretation and application through self-study and external involvement with industry groups 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 * Proven knowledge of modern quality systems, risk assessment, corrective and preventive action development and execution, and other evolving principles across the global compliance arena * Extensive Audit experience * Cross-cultural awareness and sensitivity * Excellent written and verbal communication skills, with an ability to manage stressful and confrontational situations to positive outcomes * Ability to travel extensively (up to 60% of time local/regionally/global) * Direct and increasingly responsible audit responsibilities To succeed in this role, you need to have strong engagement, communication and partner management skills, including excellent presentation and influencing skills. You can make decisions, acting courageously and communicating with conviction and inspiration. As a person, you enjoy team working and networking, and you demonstrate drive and energy in the role to make a difference. Date Posted 15-Jun-2020 Closing Date 30-Jun-2020 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 authorization and employment eligibility verification requirements.