Abaris Healthcare

1. Quality Compliance & System Management Ensure compliance with cGMP, WHO-GMP, Schedule M , and other applicable regulatory guidelines for injectable products. Oversee and manage Quality Management Systems (QMS) Deviation, Change Control, CAPA, OOS, OOT, and Risk Management. Coordinate internal audits, vendor audits , and support regulatory inspections (WHO, ISO, USFDA, etc.). Review and approve Standard Operating Procedures (SOPs), BMRs/BPRs, and validation documents . 2. FFS Production Oversight Monitor sterile manufacturing operations in the FFS line including formulation, filtration, filling, and sealing. Verify compliance of aseptic techniques and environmental monitoring in classified areas. Review and approve line clearance, in-process checks, and batch release documentation . Ensure effective execution and documentation of media fills, process validation, and equipment qualification . 3. Documentation & Record Management Maintain and control document lifecycle management in accordance with Good Documentation Practices (GDP) . Review validation master plan, cleaning validation, and stability protocols. Supervise the archival of controlled documents and batch records. 4. Training & Development Plan and conduct GMP, GDP, and aseptic handling training programs for production and QA personnel. Develop and mentor QA team to maintain high standards of quality culture. 5. Vendor & Material Assurance Approve and monitor suppliers and contract manufacturers through qualification programs. Ensure all raw materials, packaging materials, and consumables meet pre-approved specifications. 6. Regulatory & Continuous Improvement Prepare plant and team for regulatory and customer audits . Manage product recall, complaint handling , and risk evaluation . Drive continuous improvement initiatives to enhance product quality and process efficiency.