Stability Evaluator (Port Elizabeth) at Aspen Pharma Group

Job purpose

• Track stability trials and obtain stability data for all products from local and international laboratories.
• Review, evaluate and trend stability data and prepare stability reports.
• Ensure pharmaceutical compliance with regards the handling, storage, supply, control, recording and destruction of scheduled stability samples

Responsibilities

Planning and Operational Support

• Oversee work or serves as a lead technical expert in a complex area/ project.
• Provide technical advice for issues experienced by internal stakeholders
• Optimize and facilitate implementation of current processes
• Identify gaps in current policies and procedures.
• Propose changes or improvements to processes, tools, and techniques. 

Stability Sample and Data Management

• Handle, store and record scheduled stability samples according to SOP and standards.
• Issue the correct supply of scheduled stability samples to local and outsource laboratories for testing.
• Ensure the correct termination of stability trials for scheduled products that are no longer required for stability testing.
• Ensure accurate quantity of scheduled stability samples in stability chambers in accordance with legislated stock counts.
• Track and obtain stability data for all stability trials conducted at local and international laboratories.
• Record stability trials into SLIMS to track stability sample status and testing schedule.
• Prepare stability reports, evaluate results, and identify trends.
• Assist with OOS stability investigations.
• Adhere to GMP quality systems and procedures.
• Review and update relevant SOPs to reflect current practices.
• Assist with SOP training.

Reporting and Record-Keeping

• Document and store data according to SOPs and regulation
• Consolidate information for reports on weekly/ monthly basis.
• Analyse consolidated data and provide recommendations
• Compile detailed reports and consolidated documents.
• Monitor and control access to and set-up of electronic databases.

Background/experience

• National Diploma in Analytical Chemistry with 2 to 4 years’ related experience
• Stability testing experience

Specific job skills

• Advanced knowledge of MCC and ICH stability testing guidelines
• Understanding of Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives.

Competencies

• Interrogating Information
• Following Procedures
• Maintaining Accuracy
• Customer Awareness