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

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