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 robust 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.
Solid 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.

📌 Qa Executive Senior Boisar
🏢 R2R Consults
📍 Boisar