Quality Operations Specialist

Major Accountabilities

• Perform Batch Record Review and support timely and GMP-compliant batch release activities.
• Ensure compliant documentation lifecycle management, including review, approval, archiving, and control of paper-based and electronic records.
• Prepare, review and approve quality-related documentation, including operational procedures, protocols, work instructions, and controlled documents.
• Support deviation and complaint investigations, including impact assessments, investigation follow-up, and timely closure.
• Support CAPA, actions, change control, internal audit, and Health Authority inspection readiness activities, ensuring timely execution of defined actions.
• Perform batch-wise Audit Trail Reviews in accordance with the approved plan and applicable procedures.
• Perform routine QA walkthroughs and provide QA support to maintain GMP compliance within manufacturing areas.
• Collaborate with Manufacturing, QC, Microbiology, Warehouse, and other cross-functional teams to ensure timely identification, escalation, and resolution of Quality and GMP-related issues.

Obligatory Requirements

• Bachelor’s degree, preferably in Pharmacy, Chemistry, Chemical Engineering, Biology, Bioengineering, Life Sciences, or a related field.
• Good knowledge of GMP and pharmaceutical Quality Systems.
• Basic knowledge of applicable regulatory requirements.
• Strong quality mindset and awareness of GMP requirements.
• Excellent organizational skills with strong attention to detail.
• Ability to work effectively in a team and communicate clearly with cross-functional stakeholders.
• Demonstrates an appropriate sense of urgency and the ability to prioritize tasks in a dynamic operational environment.
• Good command of English, both written and spoken.

Desirable Requirements

• Previous experience or internship in Quality Assurance, Quality Control, or pharmaceutical manufacturing.
• Experience or familiarity with Batch Record Review, deviation management, batch release, or shopfloor QA activities.
• Familiarity with electronic manufacturing and Quality systems, preferably MES.
• Experience in a GMP-regulated pharmaceutical manufacturing environment is an advantage.