Company:Safe Pharma

Department:Research & Development

Location:Alexandria

Job ID:R&D - V J C 003

R&D Stability Manager

Summary:

Manage, design & control all related stability tests of new & current products ensuring compliance with internal procedures, industry regulations, and regulatory guidance.

Job requirements:

1-   Manage, design, develop & supervise stability plan & tests forall new products & current products to ensure its compliance with GMP,pharmacopoeia, quality, related standards…etc.

2- Manage, develop & monitor the implementation of CAPAs to ensure ontime implementation & check CAPA effectiveness.

3- Participate in assessment of deviations, anomalies & trends receivedfrom related department in cooperation of quality assurance.

4- Monitor the calibration & condition of testing equipment & toolsto ensure the accuracy of testing & results.

5- Communicate all related tests & reports to concerned departments(QA, QC, Registration, Export, Production…etc.) in a timely manner.

6- Revise & approve all related documents required for MOH & Exportto ensure all documents need to be sent is accurate & valid.

7- Review & approve all reports related to supplier evaluation, changesin product composition stability, product shelf life…etc.

8-  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 & strictlyimplemented to guarantee continuous improvement of stability departmentactivities and compliance with defined standards.

9- Proposeto superior any forecast and operational needs and provide periodical reportswith appropriate analysis to ensure effective & accurate updated records.

      Fulfill other related tasks as asked by management and as arising from the business

10- Approve, decline, or amend department related operating budget, CAPEX,work documents & processes workflow in relation to operational &Strategic decisions (aligned with defined standards & target businessresults)

11- Approve, decline, or decide CAPA for related R&D analysis &inspections (aligned with defined standards & target business results).

12-  Approve, decline, or amend all required documents for MOH & Exportor any other concerned bodies/Parties as per department’s standards.

13 -Approve all changes in product composition stability, product shelf life, etc.

Qualifications:

1-      Education & Experience:

2-      B.Sc. degree pharmacy, Science.

3-      From 10 to 15 years of experience in relevant fields.

4-      Behavioral Requirements:

5-      Focus on results.

6-      Communication & teamwork.

7-      Planning & follow-up.

8-      Analytical thinking.

9-      Delegation & people management.

10-  Decision making.



Years of Experience: 11

Posting Date: 17 November 2021

Application End Date: 30 December 2021

Available Vacancies: 1

Job Level: Manager

Function: R&D - Stability

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