Specialist Quality Assurance Auditor Innovative Medicine
About the Role
Specialist Quality Assurance Auditor – Innovative Medicine
Company Description
Johnson & Johnson is a healthcare company that cares about making life healthier for people over the world. Johnson & Johnson focuses on making medicines and medical tools through its Innovative Medicine and MedTech divisions. Johnson & Johnson works to solve health problems with a promise to ethics, quality and care, for patients. Johnson & Johnson teams work together in places and fields to make solutions that help patients and health systems.
Job Summary
The Specialist Quality Assurance Auditor helps R&D Quality and Pharmacovigilance compliance by planning, conducting and reporting audits. They review processes, data, facilities and service providers to keep everything in line, with standards and regulatory rules. The Specialist Quality Assurance Auditor also supports inspections, training and compliance projects. They must have knowledge about Pharmacovigilance, GVP, quality systems and auditing to keep operations compliant.
Key Responsibilities
Plan, conduct, document and report R&D Quality Assurance audits.
Support non-routine audits covering GxP and non-regulated work.
Review processes, data, facilities, systems and service providers for compliance.
Conduct or support diligence for-cause cross-functional and complex audits.
Use established audit procedures, diagnostic tools and audit plans.
Support regulatory inspections in roles.
Stay inspection-ready by completing required training.
Take part in quality and compliance projects as assigned.
Complete project work on time meeting priorities and deadlines.
Offer compliance advice to business partners on issues.
Assist stakeholders with questions about Pharmacovigilance compliance.
Spot potential compliance. Escalate serious concerns.
Keep objectivity, professionalism and confidentiality during audits.
Educational Qualification
Bachelor’s degree in Life Sciences, Pharmacy, Medicine or a similar field.
Least 2 years of Pharmacovigilance experience in pharma or biotech.
Hands-on experience in Pharmacovigilance tasks like ICSR processing, signal detection, risk management or safety surveillance.
2+ years of QA auditing experience in Pharmacovigilance or GVP audits is preferred.
Experience with external or vendor audits is a plus.
Skills Required
Pharmacovigilance operations, the day‑to‑day work that keeps medicines safe.
ICSR management, the handling of Individual Case Safety Reports.
Signal detection, the process of spotting safety signals
Safety surveillance watching of drug safety.
Risk management, the study and control of risks.
Aggregate reporting, including PSUR/PBRER and DSUR the big safety reports, for regulators.
Risk minimization activities, actions taken to reduce risk.
Pharmacovigilance compliance, following all safety rules.
GVP requirements, the guidelines that must be met.
QA auditing, quality checks to ensure standards.
Vendor oversight, supervising suppliers and partners.
PV. Databases, the software that stores safety data.
Quality Management Systems, the quality framework.
Compliance management, ensuring all laws are followed.
Data analysis, turning numbers into safety insights.
Clear. Verbal communication, speaking and writing plainly.
Good stakeholder management
Salary Structure
The estimated salary for a Specialist Quality Assurance Audito at Johnson & Johnson in India typically ranges from ₹8 Lakhs to ₹18 Lakhs per year, depending closely on your exact years of relevant auditing experience and internal leveling.
Career Development
This role builds deep expertise in Pharmacovigilance quality, GVP compliance, regulatory inspections, auditing, risk management and quality systems. With the experience professionals can grow into positions like Senior QA Auditor, Pharmacovigilance Quality Manager, PV Compliance Manager, Quality Systems Specialist or other senior Drug Safety and Quality roles.
How to Apply
Go to our job portal. Look for Specialist Quality Assurance Auditor – Innovative Medicine.
Refresh your candidate profile and upload your newest ATS‑friendly resume.
Check your qualifications, experience and skills before you submit.
Click. Finish all required details to submit your application.
Market Insights & Trends
Salary Insights
The amount of money that gets paid can be different depending on how they have been working, where they live and what kind of job they are doing. Some places pay more than others. Most good jobs include extra money for doing a good job, health insurance and flexible hours. Companies pay high salary to make sure they can get the people they want.
Hiring Trends
The number of jobs for this profile is going up every year. Hospitals and other healthcare companies are looking for people who're good, at their job and can also figure out new problems. They want who can do the work and also think on their feet to deal with the challenges of working in healthcare today.