Senior Quality Assurance Officer

About the role

We are looking for a Senior Quality Assurance Officer to lead day‑to‑day QA activities in a pharmaceutical manufacturing environment. The role ensures that products and processes comply with internal standards and regulatory requirements, focusing on deviation management, CAPA, and GMP compliance.

Key responsibilities

• Lead investigations of deviations and non‑conformities, perform root cause analysis and document findings.
• Conduct impact and risk assessments for quality events and recommend corrective actions.
• Manage CAPA processes, ensure timely implementation and verify effectiveness.
• Support GMP compliance in manufacturing and packaging areas through routine follow‑up and coordination with production teams.
• Review and approve change controls, SOPs, records and other quality documentation.
• Participate in internal audits, coordinate follow‑up on observations and action plans.
• Prepare documentation for regulatory inspections and respond to auditor requests.
• Track quality KPIs, trend data to identify recurring issues and drive improvement.
• Prepare clear reports and communicate updates to stakeholders.

Required profile

• Bachelor’s degree in Industrial Engineering, Chemical Engineering, Pharmacy or a related scientific field.
• At least 5 years of QA experience in pharmaceutical manufacturing.
• Strong knowledge of GMP, deviation, CAPA, change control and audit processes.
• Understanding of manufacturing and packaging operations.
• Excellent written communication and reporting abilities.
• Ability to work effectively with cross‑functional teams.
• Knowledge of risk management principles such as ICH guidelines is a plus.

Required skills

• GMP compliance
• CAPA management
• Root cause analysis (RCA)
• Risk assessment and management
• Change control procedures
• Audit preparation and follow‑up
• ICH guideline familiarity