Investigation & CAPA Lead – Injectable Manufacturing

Amneal Pharmaceuticals LLC; Hinoba-an; On-site; PHP 600,000 - 900,000; Full time

Job summary

Amneal Pharmaceuticals LLC in the Philippines seeks a qualified professional to support investigations into market complaints and OOS/OOT for injectable manufacturing sites. You will coordinate with QC, QA, RA, and R&D to drive timely investigations and CAPA closure while maintaining metrics and action logs.

Responsibilities include reviewing investigation reports, data analysis with Six Sigma tools, and collaboration with site teams to implement process improvements and robust product quality.

Qualifications

• Experience with injectable dosage forms and sterile unit operations.
• Strong understanding of equipment operation.
• Proactive approach toward problem solving.
• Good documentation, coordination and communication skills.

Responsibilities

• Support commercial troubleshooting/remediation and Market complaints for injectable manufacturing sites at Level 2.
• Support timely investigation/execution and to resume commercial manufacturing to meet market/sales requirements.
• Review site investigation report, Product/Method development report, and historical data trending using Six Sigma tools.
• Communication with site for root cause and CAPA, and participation in CFT discussions with sites.
• Close coordination with QC, manufacturing, QA, RA, and R&D to meet turnaround time (TAT).
• Record and follow up on meeting actions, metrics and improvement initiatives.

Skills

Analytical and problem solving

Conflict management

Proactive support management

Equipment operation understanding

Education

Master in Pharmacy

Job description

Amneal Pharmaceuticals LLC in the Philippines seeks a qualified professional to support investigations into market complaints and OOS/OOT for injectable manufacturing sites. You will coordinate with QC, QA, RA, and R&D to drive timely investigations and CAPA closure while maintaining metrics and action logs.

Responsibilities include reviewing investigation reports, data analysis with Six Sigma tools, and collaboration with site teams to implement process improvements and robust product quality.