Posted on: 20 May 2023
ID 860215

Specifications Evaluator

  • 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
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
#JP
Occupation:
Manufacturing jobs


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