Officer Quality Assurance

About the role

The Officer Quality Assurance will ensure product quality, regulatory compliance and operational excellence across manufacturing operations in a highly regulated IVD/Medical Devices environment. You will drive Quality Management System (QMS) and In‑Process Quality Assurance (IPQA) activities, supporting continuous improvement and adherence to GMP, ISO 9001 and ISO 13485 standards.

Key responsibilities

• Execute IPQA activities across fabrication, dispensing, manufacturing, packaging and dispatch to maintain consistent product quality.
• Review, update and control SOPs, batch records, calibration schedules, logbooks and other technical documentation.
• Identify deviations, non‑conformances and process risks, lead investigations and implement corrective and preventive actions (CAPA).
• Support QMS functions including market complaint handling, change controls, internal and external audits, training and compliance programs.
• Collaborate with cross‑functional teams to strengthen quality culture and drive operational excellence.

Required profile

• Graduate or post‑graduate degree in Life Sciences, Biotechnology, Microbiology, Chemistry, Pharmacy or related field.
• 2‑5 years of Quality Assurance experience, with at least 1 year in the IVD or Medical Devices industry.
• Strong knowledge of GMP, Good Documentation Practices, Change Controls, CAPA, deviations, non‑conformance management and validation.
• Familiarity with ISO 9001, ISO 13485, regulatory requirements and audit processes.

Required skills

• GMP and Good Documentation Practices (GDP)
• Change Controls, CAPA, deviation and non‑conformance management
• Validation procedures
• ISO 9001 and ISO 13485 standards
• ELISA, Clinical Chemistry, Rapid Diagnostics, Hematology manufacturing processes
• MS Office and quality documentation management tools