Job Description

Purpose of the Job

To ensure compliance of Quality Systems with GMP, regulatory, and corporate requirements through effective management of validation, change control, documentation, qualification, training, quality metrics, audits, and continuous improvement activities. The role provides quality oversight and support to manufacturing, laboratory, engineering, and regulatory functions to maintain product quality, data integrity, and regulatory compliance in an API manufacturing workplace.

Key Responsibilities

1. Collect, compile, analyze and review data related to manufacturing, testing, sourcing, deviations, stability studies, and change controls to support and maintain the validated status of products.

2. Manage and ensure the controlled issuance of Batch Manufacturing Records (BMRs) and related documentation, including assignment of batch numbers and issuance to operations for execution.

3. Manage and oversee the Change Control process, including initiation, impact assessment, review, approval, implementation, and closure of changes related to GMP systems and operations.

4. Review and approve validation protocols, reports,



and qualification documentation associated with GMP equipment, laboratory instruments, processes, cleaning activities, and computerized systems.

5. Manage GMP documentation through generation, revision, review, approval, issuance, control, and archival processes, including the Validation Master Plan (VMP).

6. Track, trend, analyze, and report Quality Metrics for site management reviews and continuous improvement initiatives.

7. Perform regulatory and quality compliance assessments, gap analyses, SOP development, and monitoring of CAPA effectiveness.

8. Provide Quality Systems support to Regulatory Affairs regarding regulatory submissions, market authorizations, and post-approval changes.

9. Manage GMP training programs, personnel qualification activities, Quality Gemba Walks, self-inspections, and internal audits as per approved procedures.

10. Review and approve lifecycle documentation associated with GMP computerized systems and ensure data integrity compliance.

📌 Quality Senior Specialist (QMS) (Malanpur)
🏢 Tapi
📍 Malanpur