R&D Stability Manager
Manage, design & control all related stability tests of new & current products ensuring compliance with internal procedures, industry regulations, and regulatory guidance.
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.
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:
17 November 2021
Application End Date:
30 December 2021
R&D - Stability