Immediate Need - Packing Manager (injectables)

Role & responsibilities Job Purpose: To lead and manage the sterile injectable packing operations for veterinary pharmaceutical products, ensuring compliance with USFDA and global regulatory requirements. Responsible for batch packing, documentation, process optimization, and team leadership in a GMP-compliant environment. Key Responsibilities: 1. Packing Operations Management Supervise and coordinate all packing activities for injectable veterinary products (vials, ampoules, PFS). Ensure compliance with cGMP, USFDA (21 CFR Part 210/211), and internal SOPs. Manage line clearance, labeling, batch coding, and container-closure integrity checks. 2. Regulatory & Documentation Compliance Ensure accurate and timely completion of Batch Packing Records (BPRs) and related documentation. Prepare and face regulatory audits (USFDA, USDA, EU GMP, etc.). Maintain documentation in compliance with data integrity and ALCOA+ principles. 3. Team Leadership & Training Lead, train, and motivate a team of packing supervisors and operators. Conduct regular training on SOPs, safety, hygiene, and cGMP practices. Ensure discipline, skill development, and productivity across shifts. 4. Material & Vendor Coordination Coordinate with SCM/procurement for timely availability of packaging materials (labels, flip-off seals, cartons). Review and approve packaging artwork and specifications in accordance with USFDA and export market requirements. 5. Continuous Improvement & Safety Implement lean practices, 5S, and Kaizen to optimize line efficiency. Ensure adherence to health and safety protocols in sterile packing areas. Lead or support investigations related to deviations, NCRs, and CAPAs. Qualifications: B.Pharm / M.Pharm / B.Sc / M.Sc in Pharmaceutical Sciences or related field Experience: 8-15 years in injectable formulation packing in a pharmaceutical environment Minimum 3 years in a managerial or supervisory role Exposure to USFDA-regulated markets and veterinary formulations preferred Key Skills: Sterile injectable packing (vial, ampoule, PFS) USFDA cGMP knowledge (21 CFR Part 211) Familiarity with veterinary product regulations (21 CFR Part 514) Strong leadership and documentation skills Handling of audits and regulatory inspections ERP systems (SAP preferred), TrackWise/LIMS familiarity Regulatory Focus: USFDA (21 CFR Parts 210, 211, 514) manufacturing, packaging & labeling of veterinary injectables USP 1207 Container Closure Integrity Testing (CCIT) DSCSA serialization as applicable GMP / cGMP / GLP / GDP applicable for injectable pharmaceuticals Working Conditions: Sterile/controlled environment (Grade C/B areas) Shift-based working may be required Must follow strict gowning and hygiene procedures