Company:Safe Pharma

Department:Research & Development

Location:Alexandria

Job ID:R&D V J C 001

R&D Documentation Manager

Summary:

Manage & control all R&D documentation activities including: Master formula, analytical methods, product formula, SOPs…etc. & guarantee that all documents are issued, maintained, stored, archived & retrieved properly throughout its life cycle.

Job requirements:


1- Monitor the process of drafting, revising & agreement on SOPs from relevant stakeholders to ensure smooth & timely                   manner flow of information.
2- Manage & design procedure & process of drafting, modifying, cancelling & periodic revision of all related documents                    (Sampling plan, analytical methods, master formula...etc).
3- Manage & monitor the implementation of CAPAs to ensure on time implementation & check CAPA effectiveness.
4- Review & supervise validation process requirements for R&D departments & communicate related documents to R&D &               related documents.
5- Act as a coordinator between Supply Chain, QA, QC, release & registration for export.
6- Revise all related documents required for MOH & Export to ensure all documents need to be sent is accurate & valid.
7- Review, propose & monitor that all policies & procedures are updated & aligned with company & government regulations,         ensure that all documents, applied form & related SOPs are updated, communicated & strictly implemented to guarantee             continuous improvement of department activities and compliance with defined standards.
8- Propose to superior any forecast and operational needs and provide periodical reports with appropriate analysis to ensure          effective & accurate updated records.
9- Fulfill other related tasks as asked by management and as arising from the business.




Qualifications:

Bachelor’s degree in Science or pharmacy

From 10 to 15 years of experience in relevant fields.

Competencies

·   

               People Management

                People Development

                Focus on Results

                Planning & Follow Up

                Communication & Teamwork

·    


Years of Experience: 11

Posting Date: 17 November 2021

Application End Date: 30 December 2021

Available Vacancies: 1

Job Level: Manager

Function: R&D - Documentation

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