Sr. Executive Documentation At Jamjoom Pharma
Role Purpose:
Sr. Executive Documentation is responsible to manage the documentation process in the Quality department. candidate will secure availability of up-to-date documents and withdrawal of obsolete ones. Sr. Executive Documentation is a part of the Quality department and will report to the manager Documentation Manager
Responsibilities:
Manage filing and archiving system of all GMP documents and maintain a robust documentation system in the quality departments.
Verify that the documentation system is in place and well-maintained all over the site.
Secure the accessibility of authorized personnel for all the documents available in the QA department.
Responsible for all document control and record control activities.
Issue, stamp, and distribute the controlled documents.
Assure that all distributed documents are up-to-date and assure withdrawing all the obsolete and invalid versions.
Assure the destruction of all obsolete copies and keeping the original document stamped with Cancelled.
Maintain the training system within all technical departments.
Issue, update, and control of master batch records.
Issue of operational copies of batch manufacturing records to production.
Handle all activities regarding regular EDA inspection visits.
Review and release of production batch
Qualifications:
Bachelor’s degree in pharmacy or science.
2 - 4 years’ experience in similar job duties especially in sterile pharmaceutical areas.
Up to date knowledge of current GMP & Good Documentation Practice as per EDA Regulatory requirements, WHO & ICH guidelines.
Working previous experience as IPC or in production is preferable.
Familiar with SAP system is preferable.
Excellent documentation and report writing skills.
Good verbal and written communication skills.
Good command of English (spoken and written)
Working knowledge in Microsoft Office applications (Specially Word and Excel).
Hard worker, team player, and adaptable to business change