
Pharmaceutical operations and supply coordination professional with 5+ years of experience in manufacturing, post-manufacturing operations, regulatory compliance, and cross-functional coordination within the pharmaceutical industry at ACG Universal Capsules Pvt. Ltd.
Experienced in production coordination, vendor interaction, quality & regulatory compliance, CAPA management, audits, documentation control, and supply follow-ups. Skilled in working with cross-functional teams including Quality, Regulatory Affairs, Supply Chain, and Production to ensure smooth execution of manufacturing and supply activities.
Seeking a role in Supply Chain Management / CMO Coordination / SCM Operations where operational and regulatory expertise can support global pharmaceutical supply operations.
CORE COMPETENCIES
Third-Party Manufacturing Coordination
Production Planning & Execution Support
Coordinating production and post-manufacturing activities ensuring timely execution aligned with supply requirements.
Managing cross-functional coordination between production, quality, logistics, and planning teams.
Supporting procurement activities including vendor coordination, consumable purchasing, and supplier development.
Handling CAPA, change control, deviations, and audit compliance as per regulatory requirements.
Participating in internal and external regulatory audits and ensuring timely closure of action items.
Managing documentation including SOPs, BMRs, validation records, and master documents.
Supporting qualification & validation activities for facility, equipment, and processes.
Tracking operational performance and preparing departmental dashboards.
Played a key role in greenfield facility installation and stabilization with automation and process improvements.
Investigating customer complaints and implementing corrective/preventive actions.
Managed production execution and ensured adherence to quality and regulatory standards.
Coordinated dispatch planning and ensured on-time material availability.
Reduced downtime and process wastage through operational monitoring.
Handled manpower coordination and production planning.
Maintained production documentation aligned with GMP requirements.
Supported customer complaint investigations and RCA activities.
REGULATORY & QUALITY EXPERIENCE
GMP/GDP compliance implementation
CAPA & deviation management
Change control system handling
Internal & external audit participation
Validation & qualification documentation review
Regulatory documentation coordination
Investigation & RCA management
Document control & SOP lifecycle management
SYSTEMS & SOFTWARE
SAP
Material & Process Tracking
Moderate QMS and Quality Management