Executive - Manufacturing Operations

Author, review, and execute Batch Manufacturing Records (BMR), Master Batch Manufacturing Records (MBMR), BMR requisitions, and issuance logbooks as authorized doer, checker, and verifier.

Prepare new BMRs and manage timely revisions in strict compliance with current Good Manufacturing Practices (cGMP) standards.

Monitor and enforce all in-process quality control (IPQC) instructions specified in batch documentation and manufacturing protocols.

Maintain daily production reports, operational logbooks, and track overall equipment effectiveness and machine utilization on a shift-by-shift basis.

Assist in drafting and executing Change Controls, Corrective and Preventive Actions (CAPA), and documentation for new manufacturing equipment commissioning.

Prepare Process Performance Qualification (PPQ) protocols, process validation protocols, and specialized study documentation.

Conduct Failure Mode and Effects Analysis (FMEA) and comprehensive quality risk assessments for manufacturing products and shop-floor processes.

Monitor and review Environmental Monitoring System (EMS) reports, assessing action/alert limit excursions and coordinating maintenance requirements.

Deliver technical and GMP training to production supervisors and technicians on newly released and revised BMRs, SOPs, and operational protocols.

Participate actively in functional cGMP training programs and ensure inspection readiness during regulatory audits.