PHARMAFull-time
Specialist Quality Assurance Auditor – Innovative Medicine
MUMBAI (IN)ONSITEPOSTED: 9/21/2026
PHARMAFull-time
HIRING ORGANIZATIONJOHNSON & JOHNSONPharmaceuticals, Healthcare & MedTech
ROLE OVERVIEW
Quality Assurance specialist focused on R&D and Pharmacovigilance auditing, regulatory inspection support, GxP compliance, and quality systems. The role requires hands-on PV experience and supports audits across global healthcare operations.
ROLE DEFINITION & RESPONSIBILITIES
- •Plan, conduct, and report R&D Quality QA routine audits
- •Support non-routine audits including due diligence, for-cause, cross-functional, complex, sensitive, and service-provider audits
- •Apply standard procedures, diagnostic tools, and audit plans
- •Support regulatory inspections in assigned roles
- •Complete required training and contribute to training materials when requested
- •Participate in quality and compliance projects while meeting milestones and timelines
- •Provide compliance consultation to business partners and escalate complex issues appropriately
Reporting Hierarchy: Reports to a Quality Assurance supervisor or manager; Works cross-functionally with R&D, Pharmacovigilance, Quality, Regulatory, and business stakeholders across global locations
* Role responsibilities and qualifications synthesized based on industry benchmark standards.
QUALIFICATIONS & REQUIREMENTS
REQUIRED QUALIFICATIONS
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related discipline
- Minimum 2 years of Pharmacovigilance experience in pharmaceutical or biotechnology industry
- Hands-on experience in PV operations such as case processing, signal detection, risk management, or safety surveillance
- Knowledge of PV regulations and guidelines including EU GVP and Asian health authority requirements
- Understanding of ICSR management, aggregate reporting, product risk management, and vendor oversight
- Strong analytical, communication, and compliance-review skills
PREFERRED QUALIFICATIONS
- •2+ years of Quality Assurance auditing experience in Pharmacovigilance or GVP audits
- •Experience auditing PV systems, processes, databases, or service providers
- •Experience with internal, external, or vendor audits
- •Experience supporting regulatory inspections
REQUIRED VERIFIED SKILLS
Pharmacovigilance
GVP
QA auditing
R&D quality
GxP
regulatory compliance
ICSR management
aggregate reporting
PSUR
PBRER
DSUR
risk management
risk minimization
vendor oversight
PV compliance
quality management systems
audit planning
audit reporting
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Benefits: Standard pharmaceutical benefits and employee programs; benefits vary by employing country and location.
The supplied posting does not disclose salary or bonus information. Compensation should therefore be assessed using the applicable market and country for the selected employing location and the candidate's PV and QA audit experience.
ORGANIZATION CONTEXT & CULTURE
Johnson & Johnson is a global healthcare company operating through Innovative Medicine and MedTech, focused on healthcare innovation and developing solutions intended to prevent, treat, and cure complex diseases.
TEAM SIZE: 130,000+ employees
INDUSTRY: Pharmaceuticals, Healthcare & MedTech
Culture: Johnson & Johnson describes an inclusive environment guided by its Credo, with emphasis on individual dignity, diversity, collaboration, compliance, and healthcare innovation.
EXPECTED CAREER ROADMAP
The role can provide progression into senior QA audit, Pharmacovigilance quality, GVP compliance, quality systems, inspection readiness, or broader R&D quality leadership positions.
APPLICATION ADVISORY
Emphasize hands-on PV operations and GVP auditing experience; highlight experience with ICSR, PSUR/PBRER, DSUR, risk management, and vendor oversight; demonstrate audit planning and reporting experience; mention regulatory inspection support and knowledge of EU GVP; quantify audit findings, compliance improvements, or corrective actions where possible.
RECOMMENDED TRAINING
1/5
READY TO SUBMIT?
Verify your capability profile and matching credentials before submitting direct applications.