391207BR
Jan 31, 2024
China
About the Role
Location: Shanghai, Beijing, Guangzhou
About the role:
Lead, support and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to the Novartis Quality Systems and Standards, Good Clin-ical Practice(GCP)/Good Pharmacovigilance Practice(GPvP) and the current GCP/PV reg-ulations. Provide GCP/PV related quality guidance and assist in the identification and im-plementation of quality assurance training needs for Global GxP Audit and other business partners. The audits performed on behalf of Global GxP Audit include all audit types across GCP and PV disciplines including internal and external targets.
Key Responsibilities：
• Plan, lead, conduct, document, report and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.
• For this entry-level global auditor role, audits will typically be limited to low risk GCP/PV activities such as Investigator site audits, single service vendors, sys-tems/process, Patient Oriented Programs, etc). Auditor may assist in supporting complex audits (Country Organizations, multiservice vendors, high risk vendors, etc).
• Provide technical guidance and training on audit activities.
• Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures. Ensure adequate efini-tion and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
• Maintain current knowledge of regulations, standards, and guidance documents.
About the role:
Lead, support and report independent GCP/PV audits and approve follow-up corrective and preventive activities according to the Novartis Quality Systems and Standards, Good Clin-ical Practice(GCP)/Good Pharmacovigilance Practice(GPvP) and the current GCP/PV reg-ulations. Provide GCP/PV related quality guidance and assist in the identification and im-plementation of quality assurance training needs for Global GxP Audit and other business partners. The audits performed on behalf of Global GxP Audit include all audit types across GCP and PV disciplines including internal and external targets.
Key Responsibilities：
• Plan, lead, conduct, document, report and follow-up of GCP/PV audits according to the requirements specified in the respective Novartis procedures as well as applicable regulations, standards, quality agreements, and guidance documented.
• For this entry-level global auditor role, audits will typically be limited to low risk GCP/PV activities such as Investigator site audits, single service vendors, sys-tems/process, Patient Oriented Programs, etc). Auditor may assist in supporting complex audits (Country Organizations, multiservice vendors, high risk vendors, etc).
• Provide technical guidance and training on audit activities.
• Ensure appropriate escalation to responsible management in case of critical audit findings and support immediate follow-up measures according to the Novartis requirements on Management Escalations and other relevant procedures. Ensure adequate efini-tion and recording of mitigation plans when applicable.
• Assess the adequacy of responses (CAPA plans) to audit findings in cooperation with Follow-up Responsible Person (FURP) and Quality Responsible Person (QARP).
• Maintain current knowledge of regulations, standards, and guidance documents.
Diversity & Inclusion / EEO
诺华致力于打造一个卓越、包容的工作环境和多元化团队，代表我们服务的患者和社区。
Role Requirements
Essential Requirements:
• Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience)
• Chinese (Mandarin, Catonese) fluency at operational and functional level (as first or second language; second language a plus) Proficiency in English is required
• 5 years GCP/GPvP/clinical /industry/health author-ity experience or equivalent; 1-2 years of GCP/PV auditing experience pre-ferred
• Willingness to travel up to 60% of time
• Ability to manage and objectively evaluate com-pliance issues;
• Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving;
• Good quality and compliance leadership and facilita-tion skills;
• Excellent verbal and written communication, organ-izational and interpersonal skills. Excellent computer skills, including Excel, Word, etc;
Desirable Requirements:
• Experience with Health Authority inspections and interaction a plus;
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
• Degree in natural/biological sciences or equivalent (or an equivalent mix of education and experience)
• Chinese (Mandarin, Catonese) fluency at operational and functional level (as first or second language; second language a plus) Proficiency in English is required
• 5 years GCP/GPvP/clinical /industry/health author-ity experience or equivalent; 1-2 years of GCP/PV auditing experience pre-ferred
• Willingness to travel up to 60% of time
• Ability to manage and objectively evaluate com-pliance issues;
• Ability to address a variety of tasks within the same timeframe while maintaining oversight; maintain a moderate degree of independence with respect to decision making and problem solving;
• Good quality and compliance leadership and facilita-tion skills;
• Excellent verbal and written communication, organ-izational and interpersonal skills. Excellent computer skills, including Excel, Word, etc;
Desirable Requirements:
• Experience with Health Authority inspections and interaction a plus;
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/sites/novartis_com/files/novartis-life-handbook.pdf
Accessibility and Accommodation:
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
