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Date: Feb 25, 2026

Location: Johor bahru, MY

Company: bioconbiolP2

Company Overview

Role Purpose

The Team Member – CQA – Internal Audit is responsible for supporting the planning, execution, documentation, and follow-up of internal quality audits across manufacturing sites, laboratories, and support functions. The role ensures that GMP compliance, data integrity, and company quality standards are upheld, and that gaps are identified, documented, and closed effectively. The role is key in promoting continuous improvement and inspection readiness across all quality-related operations.

Academic Stream

PHARMACEUTICAL SCIENCES

Work experience (in months)

36

Job Responsibility and key Decisions

Assist in the planning and scheduling of internal audits across departments and functions.

Participate in onsite and remote audits, conducting document reviews, walkthroughs, and interviews under supervision.

Document audit observations, evidence, and findings in a structured and compliant manner.

Support the drafting of internal audit reports, highlighting nonconformances and areas for improvement.

Follow up with departments to ensure timely closure of audit observations and CAPAs.

Maintain and update the internal audit tracker, audit schedules, and document repositories.

Assist in preparing sites for regulatory inspections and corporate audits, including gap assessments.

Participate in audit trend analysis to identify recurring issues or systemic gaps.

Support the development and maintenance of audit SOPs, templates, and tools.

Attend required GMP and auditrelated training to stay updated on auditing practices and compliance expectations.

Identify and document audit findings under guidance from senior auditors or audit leads.

Recommend clarifications or procedural improvements, but final decisions rest with audit leadsmanagers.

Escalate serious compliance risks or potential data integrity issues to the audit lead or manager.

Prioritize assigned tasks based on audit schedules and timelines.