REGULATORY AFFAIRS SCIENTIST at Aspen Pharma Group

Job description

BASIC JOB TASKS INCLUSIVE BUT NOT LIMITED TO THE FOLLOWING:

• Compilation and update of documents to be submitted to Regulatory Authorities. This includes compilation of Common Technical Documents.
• Compilation, update and/or amendment of internal documentation relating to testing and manufacture of APIs. This includes production and cleaning.
• Compilation of process validation protocols and reports.
• Implementation of changes in accordance with company procedures relating to the testing and manufacturing process.
• Investigating, evaluating and reporting on process performance and changes.
• Ensuring that annual product reviews are compiled according to GMP requirements.
• Ensuring that related databases are updated to allow for capturing of API data.

PERSONAL ATTRIBUTES (Brief Summary)     

• Good interpersonal skills.
• Good organizational and systems implementation skills.
• Exceptional attention to detail and accuracy.
• The ability to critically evaluate data.
• Good written and verbal communication skills.
• Excellent report writing and document reviewing skills.
• Ability to perform tasks concurrently.
• Self-motivated.

Requirements

• BSc. Degree in Chemistry or equivalent qualification as per the National Qualifications Framework (NQF).
• Good knowledge of Chemistry (Analytical and Organic).
• Proven experience in pharmaceutical, GMP or chemical manufacturing environment would be advantageous.
• Proven experience in compilation of documents would be advantageous.
• Computer Literacy, i.e. Word, Excel, Outlook, Access etc.