Regulatory Affairs Scientist (Epping) at Aspen Pharma Group

JOB REQUIREMENTS:

• Degree in Chemistry/Chemical Engineering or equivalent qualification.
• Good knowledge of chemistry (Analytical and Organic).  Statistical knowledge would be advantageous.
• Minimum of 1 year experience in pharmaceutical, cGMP or chemical manufacturing environment.
• Proven technical documentation compilation skills, with the ability to critically evaluate and interpret data.
• MS Office computer literacy, particularly the following applications: Word, Excel, Outlook, Teams, Access and PowerPoint.  Minitab and/or EXTEDO proficiency would be advantageous.

 JOB FUNCTIONS (Brief Summary)

• Compilation and/or update of manufacturing and cleaning instructions according to internal procedures and in line with regulatory expectations.
• Performing risk assessments to evaluate the potential presence of elemental, genotoxic and/or nitrosamine impurities according to relevant regulatory guidelines.
• Compilation of process qualification protocols and reports.
• Investigating, evaluating and reporting on process performance and proposed changes.
• Ensuring that annual product quality reviews are compiled according to cGMP standards and adverse trends and potential process improvements identified.
• Implementing changes according to established company procedures relating to the testing and manufacturing process.
• Compilation and update of documents to be submitted to Regulatory Authorities.  This includes compilation of Common Technical Documents.
• Ensuring that related databases are updated to allow for the capturing of API data.