Global PV QA Auditor – Compliance & Inspections

8275-Johnson & Johnson Sdn. Bhd. Legal Entity; Malaysia; On-site; MYR 100,000 - 180,000; Full time

Job summary

Johnson & Johnson Sdn. Bhd. Legal Entity in Malaysia seeks a Pharmacovigilance Auditor to lead PV audits, ensure GxP compliance, and support regulatory inspections. The role requires a life sciences degree and PV/GVP experience, with strong analytical and cross-functional collaboration skills.

The successful candidate will work within a global quality team, handle complex audits, and contribute to risk management and safety surveillance activities across PV systems.

Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline.
• Proven PV operations experience or related PV roles.
• 2+ years QA auditing experience in PV/GVP audits.

Responsibilities

• Lead planning, conduct and reporting of PV audits in GxP/non-regulated areas.
• Support regulatory inspections in various roles.
• Complete assigned training to ensure inspection readiness.
• Participate in projects and meet timelines.
• Provide consultation to business partners on routine tasks.

Skills

Data Analysis

Detail-Oriented

Quality Control

Cross-functional

Compliance

Education

Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or related discipline

Job description

Johnson & Johnson Sdn. Bhd. Legal Entity in Malaysia seeks a Pharmacovigilance Auditor to lead PV audits, ensure GxP compliance, and support regulatory inspections. The role requires a life sciences degree and PV/GVP experience, with strong analytical and cross-functional collaboration skills.

The successful candidate will work within a global quality team, handle complex audits, and contribute to risk management and safety surveillance activities across PV systems.