Key Responsibilities:
Provide corporate-level strategic oversight of quality systems across manufacturing sites, ensuring compliance with USFDA, EU-GMP, WHO-GMP and other global standards.
Drive implementational and harmonization of GMP practices, quality policies, and procedures across all sites.
Review and approve critical documents such as BMRs, Validation Protocols, and SOPs.
Lead Vendor & Supplier Qualification Programs, including audits, risk assessments, and performance monitoring.
Act as a key quality interface for clients and regulatory authorities.
Oversee quality management systems such as Change Control, Deviations, CAPA, OOS/OOT investigations, and Complaint Management across all sites.
Monitor audit outcomes and site-level compliance; escalate critical issues to senior management and support resolution strategies.
Support regulatory inspections and client audits, ensuring consistent corporate representation and effective follow-up actions.
Develop and maintain Corporate QA SOPs in line with evolving regulations.
Drive a culture of quality excellence and continuous improvement, including team mentoring and training initiatives.
Preferred Candidate Profile:
7–10 years of experience in QA / CQA / Quality Systems in API pharma industry
Solid understanding / knowledge of global regulatory requirements
Exposure to audits, inspections, and site quality oversight
Excellent communication and stakeholder management skills
📌 Corporate Quality Assurance Cqa – Sr Executive / Assistant Manager Gurugram (India)
🏢 Coral Drugs
📍 India
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