Company Overview

Role Purpose

Academic Stream

Work experience (in months)

Job Responsibility and key Decisions

Assist in the implementation and maintenance of the Quality Management System within the Drug Product manufacturing area.

Support the creation, review, and revision of quality documentation such as SOPs, batch records, and compliance reports.

Monitor compliance with GMP and internal quality standards, reporting any deviations or nonconformances.

Participate in internal and external audits by preparing required documents and supporting audit teams.

Assist in the management and tracking of deviations, investigations, CAPA, and change controls.

Maintain quality records and ensure proper documentation control.

Support training activities related to QMS and regulatory compliance for manufacturing personnel.

Collaborate with quality assurance, production, and regulatory teams to resolve compliance issues.

Help in monitoring key quality metrics and preparing reports for management review.

Promote adherence to data integrity and quality standards in all activities.

Key Decisions

Reporting compliance deviations and quality concerns to supervisors.

Suggesting improvements to quality processes and documentation control.

Supporting decisions related to audit responses and corrective actions under guidance.

Escalating critical compliance risks or quality issues to higher management.