Johnson & Johnson is hiring for the position of Specialist Quality Assurance Auditor – Innovative Medicine in Mumbai, Maharashtra. This is an excellent opportunity for professionals with a Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline and experience in Pharmacovigilance (PV) to advance their careers in pharmaceutical quality assurance and GVP auditing.

The Specialist Quality Assurance Auditor role focuses on planning, conducting, and reporting R&D Quality audits, supporting regulatory inspections, assessing pharmacovigilance processes, and helping ensure compliance with applicable GxP, GVP, corporate, and regulatory requirements.

Candidates with hands-on experience in ICSR case processing, signal detection, aggregate reporting, risk management, safety surveillance, PV compliance, or related drug safety operations may find this Johnson & Johnson Quality Assurance Auditor vacancy particularly relevant.

Johnson & Johnson QA Auditor Job Overview

Key Responsibilities

As a Specialist Quality Assurance Auditor, the selected candidate will contribute to R&D Quality and Pharmacovigilance compliance activities. Key responsibilities include:

• Lead the planning, execution, and reporting of routine R&D Quality QA audits.
• Support non-routine audits covering activities, data, facilities, processes, systems, and service providers.
• Assess adherence to corporate policies, internal quality standards, procedures, and applicable regulatory requirements.
• Support due diligence, for-cause, cross-functional, complex, and sensitive audits when required.
• Apply relevant standard operating procedures, diagnostic tools, and audit plans during audit activities.
• Support regulatory inspections in assigned roles and help maintain inspection readiness.
• Complete mandatory training requirements within established timelines.
• Assist with the preparation of training materials when requested.
• Participate in quality and compliance projects and cross-functional teams.
• Manage priorities, milestones, checkpoints, and project timelines.
• Provide consultation to business partners on routine quality and compliance matters.
• Cooperate with stakeholders on compliance inquiries and escalate complex or non-routine issues appropriately.

Pharmacovigilance Auditor Responsibilities

This vacancy has a significant Pharmacovigilance Auditor focus. Candidates should understand end-to-end PV processes and regulatory expectations.

Relevant areas include:

• Individual Case Safety Report (ICSR) management
• Pharmacovigilance case processing
• Signal detection and safety surveillance
• PSUR/PBRER preparation and processes
• Development Safety Update Reports (DSUR)
• Product risk management
• Risk minimization activities
• Vendor oversight
• PV compliance models
• Pharmacovigilance systems and databases
• Service provider oversight
• GVP compliance and audit readiness

Experience auditing PV systems, processes, safety databases, or external service providers is preferred.

Qualification & Experience

Candidates applying for the Johnson & Johnson Specialist Quality Assurance Auditor job should meet the following requirements:

Education: A Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related discipline is required.

Experience: Candidates should have a minimum of 2 years of Pharmacovigilance experience within the pharmaceutical or biotechnology industry.

Applicants should have hands-on PV experience in areas such as:

• Case processing
• Signal detection
• Risk management
• Safety surveillance
• Other pharmacovigilance-related operations

Johnson & Johnson lists 2+ years of QA auditing experience specifically involving Pharmacovigilance/GVP audits as preferred, rather than as a mandatory qualification. This may include internal, external, or vendor audits.

Pharmacovigilance Knowledge Required

Candidates should have knowledge of applicable pharmacovigilance regulations and guidelines, particularly:

• EU Good Pharmacovigilance Practices (GVP)
• Relevant Health Authority requirements
• Pharmacovigilance requirements applicable across Asian markets
• End-to-end drug safety processes
• PV quality and compliance principles
• Risk management and risk minimization
• Vendor oversight and compliance

A strong understanding of the interaction between Pharmacovigilance operations, Quality Assurance, GVP requirements, and regulatory compliance will be valuable for this position.

Skills Required

The ideal candidate should demonstrate strong analytical thinking and attention to detail, particularly when reviewing safety information and compliance evidence.

Important competencies include communication and stakeholder management, objective judgment, problem solving, data analysis, compliance management, continuous improvement, internal controls, issue escalation, quality management systems (QMS), quality standards, and process-oriented thinking.

Candidates should also be comfortable working cross-functionally and across different countries and geographies while managing multiple audits and competing priorities.

Why Consider This Opportunity?

This Johnson & Johnson Quality Assurance opportunity provides exposure to a global pharmaceutical quality environment and may allow professionals to expand their expertise beyond operational Pharmacovigilance into PV Quality Assurance, GVP auditing, inspection support, compliance management, and vendor oversight.

For PV professionals seeking career progression into pharmaceutical quality and auditing, the role offers direct involvement in quality audits, regulatory inspection support, compliance consultation, and global cross-functional activities.

The position is particularly relevant to professionals who already understand ICSR processing, aggregate reporting, risk management, safety surveillance, and other end-to-end PV processes and want to develop deeper expertise in Pharmacovigilance Quality Assurance.

Who Should Apply?

This position may be suitable for candidates who have:

• A Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field
• At least 2 years of pharmaceutical or biotech Pharmacovigilance experience
• Hands-on exposure to PV operations
• Knowledge of GVP and applicable pharmacovigilance regulations
• Understanding of ICSR management and aggregate safety reporting
• Strong analytical and compliance-oriented skills

Candidates with previous PV/GVP auditing experience may have an additional advantage because Johnson & Johnson specifically identifies this experience as preferred.

How to Apply

Application Link