Abdelouahab Zebiri

1. Production & Process Management

• Ensure production runs according to GMP (Good Manufacturing Practices).

• Plan, organize, and monitor daily production activities.

• Ensure batch records, logbooks, and documentation are properly filled.

• Monitor equipment performance and coordinate maintenance when needed.

• Set production priorities to meet deadlines and targets.

2. Quality & Compliance

• Ensure strict compliance with:

• GMP

• Internal SOPs

• Regulatory requirements (e.g., WHO, FDA, EMA if applicable)

• Perform in-process controls and ensure product quality at each step.

• Participate in deviations, CAPA, and change control processes.

• • Ensure good practices of hygiene, cleaning, and sanitization in production areas.

3. Documentation & Reporting

• Review and approve:

• Batch Manufacturing Records (BMR)

• Batch Packaging Records (BPR)

• Cleaning records

• Equipment use logs

• Prepare daily, weekly, and monthly production reports.

• Ensure proper traceability and documentation for audits.

4. Team Management & Training

• Supervise operators and technicians on the shopfloor.

• Organize training on:

• SOPs

• Safety

• New equipment

• Quality requirements

• Evaluate staff performance and ensure correct task distribution.

• Resolve conflicts and maintain a good working environment.

5. Continuous Improvement

• Identify opportunities to improve:

• Productivity

• Equipment efficiency

• Waste reduction

• Compliance

• Lead or participate in Lean, Kaizen, or Six Sigma initiatives.

• Update SOPs when processes evolve.

1. Preparation Before Coating

• Verify cleanliness of the coating room and equipment (coating pan, spray guns, pumps, filters).

• Check that the equipment is clean, calibrated, and approved for use (line clearance).

• Prepare the coating solution/suspension according to the manufacturing order (MO) and SOPs.

• Verify raw materials (polymers, pigments, plasticizers) and ensure they match the batch record.

• Perform sieving and homogenization of the coating solution if required.

2. Equipment Setup

• Install spray guns, nozzles, tubing, and ensure correct alignment.

• Configure parameters on the coating machine:

• Inlet air temperature

• Outlet air temperature

• Airflow

• Pump speed

• Gun distance

• Atomization pressure

• Drum speed

• Perform machine pre-heating to reach the required start conditions.

3. Coating Operation

• Load tablets/capsules into the coating pan safely.

• Start the coating process and follow the BMR (Batch Manufacturing Record) step-by-step.

• Continuously monitor critical process parameters (CPP):

• Spray rate

• Inlet/outlet temperatures

• Airflow

• Droplet size

• Adjust parameters as needed to ensure uniform coating.

• Avoid coating defects such as:

• Picking

• Peeling

• Cracking

• Orange peel

• Over-wetting

• Roughness

• Maintain communication with supervisors, QA, and maintenance.

4. In-Process Controls (IPC)

• Stop the machine to check coating quality at defined intervals.

• Measure:

• Tablet weight gain

• Coating uniformity

• Moisture levels

• Appearance and color

• Record all observations in the batch record.

• Take samples as required for QC.

• 5. Troubleshooting• Identify and correct issues such as:• Blocked nozzles• Spray drying• Overwetting• Tablet sticking• Variations in film thickness• Inform maintenance if mechanical issues occur.
• 6. Cleaning and Shutdown• Perform end-of-batch cleaning of:• Coating pan• Spray guns and tubing• Pumps• Filters• Follow SOPs for CIP/SIP if applicable.• Complete equipment cleaning logs and notify QA for line clearance.7. Documentation• Fill out:• Batch Manufacturing Records (BMR)• Equipment use logs• Cleaning logs• IPC sheets• Deviations (if any)• Ensure all entries are accurate, contemporaneous, and GMP-compliant.

• Operated production equipment to ensure efficient assembly processes.
• Followed safety protocols to maintain a safe working environment.
• Conducted quality checks on products to meet company standards.
• Reproduction of the same tasks of the previous experience.

• Operated machinery to produce pharmaceutical products efficiently.
• Maintained equipment to ensure optimal functioning and safety standards.
• Monitored production lines for quality control and consistency.

1. Preparation Before Coating

• Verify cleanliness of the coating room and equipment (coating pan, spray guns, pumps, filters).

• Check that the equipment is clean, calibrated, and approved for use (line clearance).

• Prepare the coating solution/suspension according to the manufacturing order (MO) and SOPs.

• Verify raw materials (polymers, pigments, plasticizers) and ensure they match the batch record.

• Perform sieving and homogenization of the coating solution if required.