Document Controller-MOH.

Summary:

- Studying scientific & legal documents needed to be prepared / executed MOH Requirements. - Gathering, evaluating, organizing needed information in variety of formats. - Implementation of quality management system & any other required standards.

Job requirements:

·       Collaborate, communicate with various sectors to gather information needed for applying MOH requirements.

·       Keep tracking of the ever-change legislation.

·       Collect & prepare regulatory documents needed through product life cycle,

-        Development phase.

-        Approval phase.

-        Post approval phase.

·       Daily monitor quarantine items in stock details for finished product, receiving item follow-up for raw materials, work center production report & lot tracing (if-needed).

·       Gathering documents & information required for MOH inspector visit whether from section or from related sectors.

·       Prepare / distribute a statement for batches /lots for proper arrangements that will be presented to the MOH inspectors for the concerned sectors.

·       Within MOH inspector visit, document controller gathering / prepares needed records / receive any documented information concerning the company to be implemented.

·       Prepare required documented information before/within/after visit of MOH inspector & take actions needed to take samples as required then send it with certificates to Cairo Pharco office.

·       Discuss any issue with QC manager to clarify any issue to the MOH inspector.

·       Distribute all decision / obligations / legal requirements / NODCAR /request for analysis completion/any MOH requirements to the concerned sectors.

·       Requesting / receiving / storage / issue / transfer samples from warehouse according to MOH inspector requirements.

·       Follow-up storage conditions and any technical requirements for the similar sample room.

·       Prepare needed documents (executing orders for finished products/ raw materials, SOPs, sending mails …….) concerning the section.

·       Retaining / archiving /disposition for documented information.

Follow & ensure compliance with the current requirements of GMP, ISO 9001, ISO 17025 & ISO 45001 and other requirements

Qualifications:

·      ·         Bachelor Degree Science or Agriculture 

     .

Years of Experience: 1

Posting Date: 5 June 2022

Application End Date: 5 July 2022

Available Vacancies: 1

Job Level: Specialist

Function: QC - Documentation

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