Posted:

June 2026

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
- Robust 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 (India)
🏢 Coral Drugs
📍 India