Quality Assurance Operations Specialist

Roles & Responsibilities
• Manage and monitor QA activities on the shopfloor to ensure product quality and GMP compliance
• Participate in site deviation and laboratory investigation (LI) related to product quality, including root cause analysis and CAPA implementation
• Review batch manufacturing records prior to release
• Ensure compliance with GMP, local regulations, and internal quality guidelines in manufacturing areas
• Implement assigned CAPAs, change controls, and effectiveness checks
• Review and track quality stock status at QA level
• Review documentation in QualiPSO or equivalent quality systems
• Conduct and participate in shopfloor meetings, quality tours, and process observations
• Support Health, Safety, and Environment (HSE) requirements, including PPE usage and safety policies
• Adhere to company values, code of ethics, data protection, and compliance principles

Qualification
• Bachelor’s degree in Pharmaceutical Sciences or related discipline

Experience
• 3–5 years of experience in the pharmaceutical industry
• Exposure to QA, shopfloor operations, IPC, or compliance activities
• Experience in solid dosage formulation (DF) area preferred

Skills
• Strong knowledge of GMP and QA documentation systems
• Root cause analysis, risk management, and problem-solving skills
• Good communication and presentation skills
• Proficiency in MS Office
• Ability to manage shopfloor quality activities independently

Key Competencies
• Result-oriented with a proactive and accountable mindset
• Ability to work cross-functionally and meet timelines
• Strong decision-making and strategic thinking skills
• Commitment to quality, integrity, and patient safety

About the Organization
The organization is a global pharmaceutical leader committed to delivering high-quality medicines while upholding the highest standards of quality, compliance, patient safety, and ethical practices across its manufacturing operations.