RA Administrator (Epping) at Aspen Pharma Group

Description

• Fine Chemicals requires the services of a highly competent Regulatory Affairs Administrator for the Regulatory Affairs Department.  To qualify for this position, the most suitable candidate must fulfil the following requirements:

Requirements
JOB REQUIREMENTS:

• A minimum of Grade 12 with mathematics and science
• Must have or be studying towards a National Diploma in Chemistry or equivalent
• Demonstrable enthusiasm for working in a highly regulated and technical environment related to the chemical manufacturing of Active Pharmaceutical Ingredients (APIs).
• Knowledge of local and international pharmaceutical regulations and guidelines would be advantageous.
• Excellent written and verbal communication skills and the ability to interact well with internal and external customers.
• Proficiency in MS Office, particularly the following applications: Word, Excel, Outlook, Teams, Access, Project, and PowerPoint.  Adobe Acrobat Pro, Adobe Sign, Veeva Vault, and EXTEDO proficiency would be highly advantageous

JOB FUNCTIONS 

• Daily issuing, archiving, and retrieving batch production records to support production and other department activities.
• Compilation, update, and/or amendment of internal documentation relating to the testing and manufacture of intermediates and/or APIs in accordance with the established Change Control Procedure.
• Implementation and withdrawal of production and quality documentation in accordance with established procedures.
• Responding to customers (both internal and external) and regulatory authority queries promptly and proactively.
• Providing the appropriate support to colleagues to ensure compliance with regulatory commitments.
• Independently formatting Word and PDF documents to ensure compliance with current regulatory requirements.
• Ensuring that all regulatory documentation is appropriately archived.
• Maintenance of documentation stored in the electronic document management system. 

PERSONAL ATTRIBUTES 

• Good interpersonal skills.
• Good organisational and systems implementation skills.
• Exceptional attention to detail and accuracy.
• Good communication (written and verbal).
• Ability to perform tasks concurrently.
• Self-motivated.