01Key Responsibilities
Receive raw materials, consumables, and equipment from approved vendors.Coordinate with QA for material release.Store materials according to specified conditions (ambient, 28C, -20C, -80C, or liquid nitrogen, as applicable).Label materials with appropriate status (Quarantine, Released, Rejected, Expired). Maintain segregation of released and quarantined materials.Label materials with appropriate status (Quarantine, Released, Rejected, Expired). Maintain segregation of released and quarantined materials.Perform routine stock verification and cycle counts.Track inventory levels and notify supervisors of low stock. Assist in annual physical inventory reconciliation.GMP material issuance to Manufacturing and QC against approved requisitions.Planning and execution of OEM vendor AMC maintenance of equipment and its accessories in coordination with users.Maintain complete traceability of issued materials.Review temperature logs and alarm records. Assist in handling temperature excursions. Coordinate receipt and storage of temperature-sensitive materials.Cross functional team document reviewSOP procedure updating and documentation
6. Primary Objectives:
Successful manufacturing of commercial and CT batches.Optimized and efficient execution of manufacturing activities.Collaboration with cross-functional teams to ensure seamless execution of manufacturing goals.Training of manufacturing team members to ensure error-free manufacturing.
7. Competencies Required:
Technical Competencies:Aseptic processing techniques.Basic understanding of GMP, GDP, and GDocP.Familiarity with warehouse and inventory management principles. Good documentation and record-keeping practices.Basic knowledge of ERP systems (e.g., SAP, Oracle, Microsoft Dynamics). Proficiency in Microsoft Excel and Word.Strong attention to detail and organizational skills.Effective communication and