QA Executive (Senior)

Key Responsibilities:

• Lead and continuously improve the Quality Management System (QMS) across manufacturing and support functions.
• Ensure compliance with GMP, regulatory and customer quality requirements.
• Oversee quality across raw materials, manufacturing, packaging, warehousing and product release.
• Lead EU, USFDA, CE/MDR, customer and certification audits, including CAPA and closure of observations.
• Manage deviations, non-conformances, CAPA, change controls, risk assessments and quality complaints.
• Drive continuous improvement, validation, root cause analysis and quality performance initiatives.
• Manage supplier quality, audits and supplier development.
• Ensure strong documentation, data integrity, quality KPIs and management reporting.

Requirements:

• Bachelors/Masters degree in Pharmacy, Microbiology, Biotechnology, Chemistry, Life Sciences or related field.
• More than 8 years of QA experience in Pharma, Medical Devices, Infection Prevention, Healthcare Manufacturing or Specialty Chemicals.
• Strong expertise in QMS, CAPA, Change Control, Risk Management, Validation and Audits.
• Proven experience leading EU, USFDA and CE/MDR audits.
• Knowledge of GMP, global regulatory standards, ERP/QMS systems and quality analytics.