IPQA Operations Lead - Pharma Manufacturing

Novugen; Nilai; On-site; MYR 180,000 - 240,000; Full time

Job summary

Novugen, a Malaysia-based pharmaceutical company, seeks an Associate Manager to oversee in-process quality assurance activities within GMP-controlled manufacturing. You will supervise IPQA operations, monitor processes, review batch documentation, and implement CAPA to ensure product quality and regulatory compliance.

You will collaborate with Production, Quality Control, and cross-functional teams to drive continuous improvement and ensure readiness for regulatory inspections.

Qualifications

• Must have strong IPQA knowledge and experience in GMP-regulated pharma operations.
• At least 8 years in pharmaceutical manufacturing with a minimum of 3 years in supervisory roles.
• Solid understanding of end-to-end pharmaceutical production processes.
• Willingness to work at Bandar Enstek, Nilai, Malaysia.

Responsibilities

• Prepare and review SOPs for the QA department.
• Execute day-to-day IPQA activities in line with SOPs.
• Supervise and train staff on SOPs and regulatory requirements.
• Review Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) for batch release.
• Review test results and ensure IPQA compliance with procedures.
• Support QMS activities including change control, deviations, CAPA, and risk management.
• Prepare, review or revise IPQA documents and validation-related records.
• Review qualification and validation documents (process, cleaning, computer systems).
• Assist with internal audits and regulatory inspections.

Skills

IPQA knowledge

Supervisory experience

Quality systems

Education

Bachelor's degree in Science

Job description

Novugen, a Malaysia-based pharmaceutical company, seeks an Associate Manager to oversee in-process quality assurance activities within GMP-controlled manufacturing. You will supervise IPQA operations, monitor processes, review batch documentation, and implement CAPA to ensure product quality and regulatory compliance.

You will collaborate with Production, Quality Control, and cross-functional teams to drive continuous improvement and ensure readiness for regulatory inspections.