Quality Senior Specialist (QMS)

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 environment.

Key Responsibilities

• Data Management Analysis: 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.
• Batch Documentation Control: 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.
• Change Control Management: Oversee the Change Control process, including initiation, impact assessment, review, approval, implementation, and closure of changes related to GMP systems and operations.
• Validation Qualification Oversight: Review and approve validation protocols, reports, and qualification documentation associated with GMP equipment, laboratory instruments, processes, cleaning activities, and computerized systems
• GMP Documentation Management: Manage GMP documentation through generation, revision, review, approval, issuance, control, and archival processes, including the Validation Master Plan (VMP).
• Quality Metrics Reporting: Track, trend, analyze, and report Quality Metrics for site management reviews and continuous improvement initiatives.
• Compliance Continuous Improvement: Perform regulatory and quality compliance assessments, gap analyses, SOP development, and monitoring of CAPA effectiveness.
• Regulatory Support: Provide Quality Systems support to Regulatory Affairs regarding regulatory submissions, market authorizations, and post-approval changes.
• Training Audit Programs: Manage GMP training programs, personnel qualification activities, Quality Gemba Walks, self-inspections, and internal audits as per approved procedures.
• Computerized Systems Compliance: Review and approve lifecycle documentation associated with GMP computerized systems and ensure data integrity compliance. Qualifications

Qualification Experience

Education: MSc- Chem.

Experience: 5-6 Years in Pharma API