Manager- Quality OSD Value Stream

Role Overview

Core Quality Responsibilities

• Monitor Good Documentation Practices, batch records, logbooks, labels, gowning, cleanliness, environmental conditions, equipment status, SOP adherence, and manufacturing activities.
• Review and approve manufacturing deviations, complaints, recalls, investigations, CAPA, and change controls.
• Perform site inspections and monitor self-inspections and GMP inspection CAPA compliance.
• Implement the Quality Improvement Plan and coordinate with cross-functional teams on quality culture.
• Approve Batch Manufacturing Records and Batch Packaging Records.

Product Lifecycle Management

• Lead QA oversight for technology transfer, process validation, commercial manufacturing, continued process verification, and product discontinuation.
• Review APQR/PQR trends, ongoing stability programs, lifecycle risk assessments, and continuous improvement initiatives.
• Review technical department SOPs, risk assessments, and other GMP documents from a quality perspective.

Batch Release and Compliance

• Lead batch document audits and retention sample checking.
• Ensure shipment checks, line clearance, line release, and in-process quality checks comply with approved procedures.
• Develop training on batch release, documentation, compliance standards, and audit readiness.
• Make the final usage decision after reviewing complete batch documentation.
• Address batch compliance issues and manage batch release priorities.

Validation and HSE

• Review facility, equipment, process, and cleaning qualification and validation documents.
• Review facility and utility layouts for related plants.
• Maintain a safe and healthy work environment and monitor compliance with HSE requirements.
• Lead incident investigations, root cause analysis, corrective and preventive actions, and environmental performance initiatives.

Qualifications

• Bachelor of Pharmacy degree.
• Minimum 10+ years of experience in Quality Assurance oversight of oral solid dosage manufacturing operations.
• Experience with batch release and product lifecycle management.
• Good experience with quality management systems.
• Good knowledge and command of cGXP.
• Knowledge of risk assessment.
• Excellent oral and written communication skills in English.