Machine Operator Colombia

CESAR MARTINEZ

EXPERIENCE

**** - ****

MACHINE OPERATOR (COMPRESSION OP, PACKING OP, LUQUID CAPSULES, OP

& COATER, GUMMIES OP), ION LABS

Steps necessary for batch registration in order of

Here are some possible steps for each stage of batch registration.

+ Pre-Execution - Planning

* During Manufacturing

+ After completing the batch

Pre-Execution - Planning

+ Review the Master Lot Record (MBR) or Master Formula Record (MFR) for product and

lot size.

+ The MBR contains the instructions, recipe or formula, and the specific manufacturing

process for a particular product.

* Verify that all raw materials, packaging equipment and personnel are available and

comply with the specifications and requirements of the MBR.

+ Perform any necessary calibration, cleaning, sanitization or maintenance of equipment

and facilities.

+ Label all materials and equipment with the lot number. the name of the product, the

expiration date and other relevant information.

+ Prepare the necessary reagent solutions or media according to the MBR.

During Manufacturing

+ Follow the work instructions for each station or stage of production as specified in the

MBR.

+ Record the start and end time, operator name, equipment used, material lot number,

process parameters, performance, and any deviations or incidents.

+ Perform any necessary sampling, testing, or quality control procedures as specified in the

MBR.

+ Record the results of the tests, the acceptance criteria and any deviation or incidence.

* Document any adjustments or corrections in the updated process to the process or

product in accordance with the MBR.

Transfer the product to the next production station or stage or to the storage area

according to the MBR.

After completing the Bundle

+ Carry out any necessary cleaning, sanitizing or maintenance of the equipment and

instructions used in the lot.

+ Verify that all records are complete, accurate, and consistent with the MBR.

+ Review and approve batch registration by authorized personnel.

+ Store the batch record in a secure location in accordance with regulatory requirements.

Some important steps to highlight

+ Verify that all materials, equipment and personnel comply with the specifications and

requirements of the MBR before starting the batch.

+ Follow work instructions and quality procedures exactly as specified in the MBR during

the batch.

+ Document each step of the process and record any deviations or incidents that occur

during the batch.

+ Review and approve the batch record by authorized personnel after batch completion.

EDUCATION

Sim6n Bolivar, La Unién Valle, Colombia - Primary

General Santander, Sevilla Valle, Colombia - HS

Instituto Técnico industrial Cali, Valle, Colombia - College

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