A Corporate Quality Assurance (CQA) role in the pharmaceutical industry establishes and governs global quality policies, ensuring company-wide compliance with regulatory standards (e.g., FDA). Responsibilities include standardizing processes, directing internal and external audits, overseeing risk management, and leading continuous improvement across all manufacturing sites .
Key Responsibilities:
- Policy Formulation: Develops and harmonizes global Standard Operating Procedures (SOPs) and corporate quality manuals across multiple sites.
- Compliance & Auditing: Conducts corporate audits, ensures inspection readiness, and manages interactions with global regulatory health authorities.
- Risk & CAPA Oversight: Oversees quality risk management and tracks overarching Corrective and Preventive Actions (CAPA)
to resolve root causes of major deviations.
- System Standardization: Maintains oversight of change controls, vendor qualifications, and annual product reviews organization-wide.
- Training & Culture: Drives a unified culture of quality and compliance, designing corporate-wide training matrices for continuous GMP adherence.
Core Competencies:
Requires deep expertise in global Valuable Manufacturing Practices (GMP) and ICH Guidelines, alongside strong risk-analysis and cross-functional leadership skills.
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📌 Corporate Quality Assurance Officer (Ahmedabad)
🏢 Medwise Overseas
📍 Ahmedabad