Job Description

Overview

• Lead scientific investigations in Stability management
• Develop systems and processes for conducting investigations within
• GMP requirements
• Evaluate stability results for chemical stability of products and degradation trends
• Investigate spec alerts (out of spec results) or out of trend results
• Trend and analyse stability data to predict shelf life
• Assist with defining and justifying stability specifications

ResponsibilitiesPlanning and Operational Support

• Provide technical and operational input on operational planning of the unit and on the prioritisation of objectives
• Determine, request and allocate assets and resources for fulfilment of work objectives, and monitor its use
• Apply advanced understanding of area of specialisation
• Analyse concepts and suggest streamlined procedures
• Identify training needs of QC staff

Deviations Investigations

• Lead all stability investigations within the QC Lab
• Lead the identification, investigation and reporting of stability
• deviations, and other nonconformities according to GMP requirement and SOPs
• Identify OOS data trends to establish any systematic issues in product, process, or testing
• Implement plans to reduce and mitigate OOSs
• Perform impact and risk assessments of CAPA plans on process

Reporting and Record-Keeping

• Compile complex reports and documents according to GMP requirements
• Update records and systems as required
• Ensure that recordkeeping complies with legal requirements
• Monitor and control access to databases in area of responsibility

Background/experience

• Post Graduate Degree in Chemistry, Biochemistry or Pharmaceutical science with 2 to 4 years related experience
• Experience in synthetic chemistry or pharmaceutical chemistry

Specific job skills

• Extensive experience in scientific principles and laboratory techniques and methodologies
• Scientific report writing skills
• Understanding of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies

• Information Gathering
• Interrogating Information
• Offering Insights

Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.

Aspen Pharmacare