Company:Safe Pharma

Department:Research & Development

Location:Alexandria

Job ID:R&D M

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:

Duties and Responsibilities:
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.

General Roles:
1- Comply with company policy for environmental, health and safety, observe environmental, health and safety related signs and be familiar with the emergency plans.
2- Work in a safe manner that does not endanger self or co-workers and Report all unsafe conditions as soon as is reasonably possible.
3- Ensure compliance with SOP’s, policies and guidelines.
4- Complete mandatory training in assigned timelines upon hire as well as when new policies, SOP's, guidance are issued and Participate in personnel development and training sessions as required.


Qualifications:

B.Sc. degree in science  or pharmacy or equivalent field of education.

From 10 to 15 years of experience in relevant field.



Years of Experience: 13

Posting Date: 23 February 2021

Application End Date: 17 March 2021

Available Vacancies: 1

Job Level: Manager

Function: R&D - Documentation

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