Operational Quality Assurance Officer

About the role

The Operational Quality Assurance Officer ensures that all manufacturing processes comply with GMP standards and maintains inspection readiness. You will provide first‑line support to operational teams, drive a proactive quality culture, and act as a key decision‑maker for quality escalations.

Key responsibilities

• Monitor GMP compliance across production, warehouse, utilities, and laboratory areas through spot‑checks and oversight shifts.
• Review and approve quality documentation such as SOPs, master batch records, and BOMs before product release.
• Oversee sampling of retained finished product batches and ensure proper execution of OQ measures during routine and validation batches.
• Act as QA reviewer for deviations, lead root‑cause analysis, and manage incident reporting and customer complaint investigations.
• Support cross‑functional teams by providing quality input for management monitoring, CCRs, and EHS/GPS implementations.
• Promote a “Quality Starts With Me” culture through coaching, training, and delivery of Stop‑for‑Quality topics.

Required profile

• University degree in Pharmacy.
• Minimum of one year of experience in the pharmaceutical industry.

Required skills

• Good Manufacturing Practices (GMP) knowledge.
• ALCOA+ documentation principles.
• SOP and batch record review.
• Sampling and OQ (Operational Qualification) execution.
• Validation and deviation management.
• Root‑cause analysis (RCA) and risk assessment.
• Quality oversight and inspection readiness.