About this role
Execute batch manufacturing activities as per approved BMR, SOPs, and validated process parameters.
Monitor and control operations such as
Raw material charging
Reaction
Heating and cooling
pH adjustment
Extraction
Filtration
Centrifugation
Distillation
Solvent recovery
Drying
Milling and sieving
Packing
Monitor critical process parameters such as temperature, pressure, pH, vacuum, agitation, addition rate, and reaction time.
Ensure batches are executed within approved process parameters and planned cycle time.
Monitor batch yield, process losses, solvent consumption, and productivity.
Escalate abnormal process conditions and equipment issues to the Production Manager.
Ensure accurate and timely completion of BMRs, logbooks, equipment records, checklists, and other GMP documents.
Follow cGMP, SOPs, Good Documentation Practices (GDP), and data-integrity requirements.
Ensure proper line clearance, equipment status labeling, cleaning, and area readiness.
Report and support investigation of deviations, process abnormalities, yield variations, and batch failures.
Support implementation of CAPA, change controls, and corrective/preventive actions.
Maintain the production area in an audit-ready condition.
Coordinate with Warehouse for timely availability of raw materials, solvents, and packing materials.
Coordinate with Engineering/Maintenance for equipment breakdowns, preventive maintenance, and troubleshooting.
Coordinate with EHS for safe handling of chemicals, solvents, gases, and hazardous materials.
Coordinate with Planning and Production management to achieve daily and monthly production targets.
Tired of cold applications?
Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
Know someone who'd be great for this?