- 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
- 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
- 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
- Evaluate analytical methods for new specification/products
- Verify that laboratories are capable of performing an analytical method reliably and precisely for its intended use
- 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
Background/experience
- National Diploma in Analytical Chemistry/Microbiology with 2 to 4 years related experience
- Laboratory and analytical methodology experience
- 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
- Interrogating Information
- Following Procedures
- Maintaining Accuracy
- Customer Awareness
