Company:Safe Pharma

Department:Research & Development

Location:Alexandria

Job ID:R&D M2

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 for all new products & current products to ensure its compliance with GMP, pharmacopeia, quality, related standards…etc.

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

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

4-      Monitor the calibration & condition of testing equipment & tools to 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 & Export to ensure all documents need to be sent is accurate & valid.

7-      Review & approve all reports related to supplier evaluation, changes in 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 & strictly implemented to guarantee continuous improvement of stability department activities and compliance with defined standards.

9-      Propose to superior any forecast and operational needs and provide periodical reports with 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 business results)

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 & Export or 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: 25 February 2021

Application End Date: 31 May 2021

Available Vacancies: 1

Job Level: Manager

Function: R&D - Stability

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