Specifications Evaluator at Aspen Pharma Group

Description

• Create and maintain specifications and method of analysis documents for all products manufactured in compliance with Pharmacopoeial requirements and regulatory body guidelines
• Initiate and manage change controls for updates to specifications and method of analysis documentation
• Verify AMTs and testing methods for intended use
• Handle queries related to site specifications and methods of analysis

Requirements

Planning and Operational Support

• Oversees work or serves as a lead technical expert in a complex area/ project
• Provide technical advice to internal stakeholders
• Optimise and facilitate implementation of current processes
• Identify gaps in current policies and procedures
• Propose changes or improvements to processes, tools, and techniques

 Specifications Maintenance and Upgrades

• Compile new, or update existing raw material and finished product specifications and method of analysis documents using appropriate data and template
• Circulate documents for review and approval, and issue final document for use within intended deadlines
• Issue required number of control copies to relevant departments
• Perform routine specification updates based on evaluation and interpretation of current vs. latest Pharmacopoeial requirements, supplier specifications and methods of analysis, and DMFs
• Initiate and manage change controls to update specifications and MOA documentation based on adequate supporting information
• Evaluate and review impact of requests for changes, and submit changes for approval
• Handle queries related to specifications and MOA for raw materials and finished products  

Analytical Method Transfers

• Evaluate analytical methods for new specification/products
• Verify that laboratories are capable of performing an analytical method reliably and precisely for its intended use

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 and standardised reports and consolidated documents
• Monitor and control access to and set-up of electronic databases

Requirements

Background/experience

• National Diploma in Analytical Chemistry/Microbiology with 2 to 4 years’ related experience
• Laboratory and analytical methodology experience

Specific job skills

• Advanced knowledge of multiple laboratory techniques and methodology
• Advanced understanding of pharmacopoeial requirements and regulatory body guidelines for specifications and methods of analysis
• Knowledge and understanding of emerging analytical techniques and procedures
• 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