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 Responsibilities and duties in detail:


Maintain policies and SOP's related to the QMS in compliance with GLPs, ISO 22000, ISO 17025 & ISO 9001 and ensure proper implementation by the staff.


Ensuring that the plant system is up to the current standards, and JFDA standards always by performing planned audits.


Review the reports and Batch Record issued by plant and follow up the computer copy.


Ensure the proper distribution, access, retrieval, and use of QMS documents with concerned departments.


Responsible for storage and preservation of QMS documents.


Daily follow-up on production and check the process is performed by operator correctly.


Take the sample from production during the process and send the sample to (IPC).


Take the sample from finished product and store as retained sample.


Follow-up the received and dispatching process.


Responsible for change control, Retention, and disposition of QMS documents.


Issuing and maintaining logbooks and notebooks.


Follow up on calibration for plant instruments and preventive maintenance program and review final reports.


Update the training plan and training list for all employees and maintain all related documents.


Control, update, and maintain the documents.


Follow up of internal and external audits findings to ensure proper handling.


Follow-up of corrective actions, improvement suggestions, Recall and customer 


complaints to ensure effective handling.


Report any needs for training, resources, requirements, and any suggestions that lead to improvements in the work. 


Check and follow-up the usage logbook for plant (machine, instrument, columns …etc)


Required reports:


Internal Audit results/ follow up report.


NCR Reports


CAPA Reports


Any other reports related to his field of work requested by his direct manager.