Title: Operator - Minor Room (Making)
Company Name: Advanced Chemical Industries PLC (ACI)
Vacancy: --
Age: Na
Job Location: Chattogram
Salary: Negotiable
Experience:
A. KNOWLEDGE
System Operations
• Minor Room Infrastructure: Deep understanding of precision weighing systems, localized exhaust ventilation (LEV), laminar flow booths, and material handling equipment.
• Regulatory Compliance: Proficiency in Good Manufacturing Practices (GMP), dust explosion prevention (ATEX/DSEAR), and strict adherence to SOPs for raw material handling and cross-contamination prevention.
Monitoring & Analysis
• Technical Methodologies: Expertise in gravimetric measurement principles, potency calculations, and environmental monitoring (particulate counts, humidity/temperature sensitivity).
• Instrumentation: Proficiency in using analytical balances, moisture analyzers, barcode scanners, and containment monitoring tools to ensure batch accuracy.
Operational Analytics
• Data Interpretation: Advanced ability to reconcile material yields, analyze weighing deviations, and perform Root Cause Analysis (RCA) on batch discrepancies or environmental excursions.
B. SKILLS & ABILITIES
Technical & Maintenance
• System Proficiency: Hands-on experience with MES (Manufacturing Execution Systems), PLC-controlled dispensing units, and ERP (SAP/Oracle) for real-time inventory and batch tracking.
• Maintenance Excellence: Expert in overseeing the daily verification and routine maintenance of high-precision balances and specialized HEPA filtration systems.
• Calibration & Troubleshooting: Skilled in performing daily weight checks (external/internal calibration) and diagnosing mechanical faults in automated dispensing or air-handling equipment.
Social & Leadership
• Leadership: Proven ability to lead dispensing teams, manage rigorous shift handovers, and foster a "Quality-First" culture in a high-stakes environment.
• Technical Communication: Translating complex batch data and deviation reports into clear summaries for Quality Assurance (QA) and Production management.
• Stakeholder Management: Coordinating with Warehouse/Logistics for material staging and QA for sampling and clearance approvals.
Resource Management
• Operational Efficiency: Optimizing material throughput, reducing weighing cycle times, and tracking Right-First-Time (RFT) metrics for dispensing operations.
• Inventory & Cost Control: Overseeing the management of high-value active ingredients (APIs), excipients, and specialized PPE/consumables to minimize waste.
C. ATTITUDE
• Standard-Driven: Uncompromising commitment to hygiene, gowning protocols, and the precision required for potent compound handling.
• Solution-Oriented: A proactive mindset focused on identifying potential contamination risks or process bottlenecks before they affect batch quality.
• Adaptable & Resilient: Calm and methodical during high-volume production schedules or when managing urgent material re-sampling requests.
• Continuous Improvement: Embracing Lean/5S principles to maintain an organized, sterile, and highly efficient Minor Room environment.
D. OTHER JOB REQUIREMENTS
• Certification: Specialized training in GMP/HACCP, hazardous material handling, or Six Sigma Yellow/Green Belt.
• Physicality: Ability to wear full respiratory protection (PAPR/Masks), stand for extended periods, and handle raw material containers safely.
• Flexibility: Availability for rotating shifts and weekend coverage to meet production demand and cleaning/sanitization schedules.
Batch & Slurry Preparation Operations
• Ensure smooth preparation of batches and slurry as per Batch Manufacturing Record (BMR), approved formulation, and SOP.
• Handle raw material receiving from stores, staging, weighing, and charging on time to prevent production interruption.
• Operate and monitor mixing tanks, agitators, slurry prep systems, and supporting equipment to ensure uniform blending and homogeneity.
• Maintain correct sequence of charging to avoid process instability, lump formation, incomplete mixing, or formulation errors
Process Parameter Monitoring & Control
• Monitor and maintain all process parameters within the defined range (mixing time, RPM, temperature, viscosity, pH, density, slurry consistency, transfer pressure, etc.).
• Ensure accurate and timely recording of parameters and process conditions in log sheets and batch records.
• Identify early trends of deviation and take immediate corrective actions to prevent batch rejection, rework, or quality non-conformance.
• Report abnormalities or recurring deviations to Supervisor/Production/QA and support investigation and corrective actions.
Quality Compliance & IPQC Coordination
• Coordinate with IPQC for sampling, testing, and timely release of batch to ensure uninterrupted production flow.
• Ensure that all required in-process quality checks are completed and cleared before transferring batch to next stage.
• Maintain compliance with GMP, hygiene standards, and contamination prevention practices during batch preparation and holding.
• Support IPQC/QA/QC in investigations of any deviation, abnormality, contamination risk, or quality non-conformance.
Batch Transfer & Wastage Control
• Ensure timely transfer of batch to downstream operations based on production plan and release status.
• Minimize transportation loss by ensuring proper connections, pressure controls, line recovery practices, and safe handling of batch transfer systems.
• Ensure minimum wastage by following correct recovery procedures, avoiding product spillage, and maximizing batch yield.
• Monitor and report wastage and loss trends to support continuous improvement actions.
Raw Material Handling, Documentation & Reconciliation
• Maintain proper documentation of all raw materials used (RM lot no., quantity, expiry, usage, return, etc.).
• Ensure accurate raw material reconciliation and prepare reconciliation reports as per SOP requirements.
• Maintain batch production records, process logs, WIP status, and deviations documentation accurately and timely.
• Ensure traceability compliance through correct labeling and segregation of batches, intermediates, and pipelines
GMP, Hygiene, Safety & 5S in Minor Room
• Ensure GMP compliance and strict cleanliness of the Making/Minor Room, equipment, and accessories.
• Perform scheduled cleaning and sanitation of tanks, pipelines, tools, and work areas as per cleaning plan.
• Ensure proper use of PPE and compliance with safety rules, chemical handling practices, and safe operational procedures.
• Maintain 5S discipline, including proper housekeeping, waste disposal, and safe storage of materials and tools