S Maln

Conducts internal and external audits, ensuring thorough follow-up and implementation of improvement measures. Demonstrates proficiency in corrective action and CAPA effectiveness, contributing to continuous improvement. Prepares, updates, and distributes SOPs, Master Formulas, Methods of Analysis, and Specifications with meticulous attention to detail. Executes rigorous approval processes for Bill of Materials, ensuring accuracy and compliance. Ensures GMP compliance in the manufacturing area, upholding quality standards and regulatory requirements. Manages approval processes for specifications, master formulas, and methods of analysis, maintaining precision. Conducts supplier qualification processes, ensuring reliable and high-quality partnerships. Expertly oversees batch manufacturing review processes, ensuring adherence to established protocols. Manages approval for secondary and primary packaging material specifications, ensuring compliance. Leads the review and enhancement of the documentation system efficiency.

Proven expertise in overseeing production processes, ensuring accuracy, efficiency, and compliance with SOPs and cGMPs. Proficient in managing deviation, change control, CAPA, and gap analysis systems, focusing on effective solutions. Skilled in risk assessment and root cause analysis to enhance operational efficiency. Conducts internal/external audits, ensuring follow-up and implementation of improvement measures. Provides periodic and induction training on industry guidelines and best practices. Prepares, updates, and distributes SOPs, Master Formulas, Methods of Analysis, and Specifications. Handles artwork review, distribution, and approval based on approved specifications. Manages complaints, recalls, and claims, ensuring prompt resolution. Expertise in Batch Manufacturing Records (BMRs), Packaging Instructions (PBRs), and Annual Product Quality Review. Actively participates in thermal mapping, machine qualification/calibration, and validation activities.