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.

- 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.

📌 QA Executive (Senior) (Boisar)
🏢 R2R Consults
📍 Boisar