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 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.
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.
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
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.
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:
25 February 2021
Application End Date:
31 May 2021
R&D - Stability