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AstraZeneca
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Senior Auditor Cell Therapy Quality
Healthcare Medical
Company shared salary
NA
Market rate
4,500 GBP–7,500 GBP/mo (54,000 GBP–90,000 GBP/yr)
Based on similar roles (title + domain + location).
Responsibilities
- ● Conduct independent appraisals of quality and compliance systems within technically advanced manufacturing settings.
- ● Perform complex and demanding domestic and international (subject to experience) audits of suppliers of raw materials, packaging components, drug substance or other process intermediates, and finished drug products, or contracted services, in accordance with cGMP's, ISO Standards, IPEC, ICH Q7A and company procedures.
- ● Plan, coordinate and conduct scheduled or unscheduled cGMP audits of complex internal AstraZeneca Operational departments to ensure compliance to cGMP's and AstraZeneca standards.
- ● Provide clear and scientifically/technically justified interpretations and support for any audit findings and proposed corrective and preventive actions.
- ● Liaise directly with local AZ and/or regional and global senior management, where necessary, to ensure issues are understood and proposed actions are acceptable.
- ● Interpret and apply cGMP regulations and expectations.
- ● Demonstrate proven written and oral skills with experience working in cross-cultural 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.
- ● Develop and interpret audit findings across the scope of the Global Quality Audit (GQA) in order to communicate trends and provide recommendations to address such developing trends in a proactive manner.
- ● While maintaining independence, work closely with other QA colleagues to assure common understanding of developing interpretations of cGMP.
- ● Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role, complete all required training on the AZ Code of Ethics and supporting Policies and Standards on time, and report potential issues of non-compliance.
Requirements
- ● 10 years experience in a QA environment with increasingly responsible job requirements including audit experience.
- ● Extensive knowledge of Cell Therapy Products and Cell Therapy Specific Regulations.
- ● Bachelor's degree in a scientific discipline.
- ● AZ business language in English.
- ● Self-directed and highly motivated team player with solid organizational capabilities.
Credential Requirements
for United Kingdom
Requirements shown are for Indian professionals relocating to United Kingdom.
🔴
Must have to work
PLAB 1 + PLAB 2
General Medical Council
Cost: GBP 1,000–2,000
Timeline: 6–18 months
🔴
Must have to work
NMC CBT + OSCE
Nursing and Midwifery Council
Cost: GBP 1,000–2,000
Timeline: 6–12 months
🔴
Must have to work
GPhC OSPAP
General Pharmaceutical Council
Cost: GBP 6,000–10,000
Timeline: 1 year
🔴
Must have to work
GDC ORE Part 1 + Part 2
General Dental Council
Cost: GBP 2,000–4,000
Timeline: 1–2 years
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