RD - Stability Specialist At Pharco B International
Company:Pharco B International
Department:Research & Development
Location:Alexandria
Job ID:PBI-RD-S-SP
R&D - Stability Specialist
Summary:
Perform physical and chemical analysis of stability samples.
Job requirements:
Labeling and introducing of stability samples to storage facility to conduct stability testing within one month of production.
Withdraw stability samples on daily basis or when required to conduct physical and chemical analysis.
Conduct analysis of stability samples, including any outsourcing analysis, to ensure that physical and chemical quality attributes are within the acceptance criteria.
Discard stability samples after analysis on weekly basis to comply with EHS requirements.
Report any OOS to senior analyst to perform OOS investigation.
Check the validity of all reagents and working standards to comply with GLP.
Report any shortage concerning reagents and working standards at the end of analysis to perform purchase order.
Report any shortage concerning consumable analysis tools (glassware, syringes, filters and spare parts) at the end of analysis to perform purchase order.
Perform periodic monitoring of stability chambers (temperature and humidity as outlined in concerned SOP) to ensure compliance with stability guidelines (WHO 2018 & MOH).
Perform daily check of lab instruments, as needed, to ensure compliance with GLP.
Perform daily monitoring of stability lab condition (temperature and humidity) to ensure compliance with GLP
Follow up installation, verification, calibration and performance qualification of stability lab instruments to ensure compliance with GLP guidelines.
Report any deviation concerning laboratory instrument(s), stability chambers or method of analysis to stability senior.
Follow up EHS requirement to ensure compliance of stability lab with ISO 45001 requirements.
Qualifications:
B.Sc. degree in Pharmacy or Science
Years of Experience: 1
Posting Date: 16 June 2021
Application End Date: 15 July 2021
Available Vacancies: 1
Job Level: Specialist
Function: R&D - Stability