Analytical Subject Matter Expert (SME) at Aspen Pharma Group

Description
Overview

• Provide expert inputs and lead the resolution of problematic scientific investigations in the QC Lab.
• Review emerging analytical technologies, assess feasibility, establish a business case and implement best practices when necessary.
• Provide expert scientific coaching to analytical teams.
• Develop systems and processes for conducting investigations within GMP requirements.
• Evaluate analytical equipment and techniques.
• Reduce Laboratory OOS with effective Preventative Actions

Requirements
Responsibilities

• Troubleshooting and Deviations Investigations
• Lead all scientific investigations within the QC Lab for raw material, finished product, packaging, analytical method development / validation and stability testing.
• Troubleshoot and identify the root cause of analytical issues encountered during analysis.
• Lead the identification, investigation and reporting of OOSs, deviations, and other nonconformities according to GMP requirement and SOPs.
• Generate scientific motivations in response to Regulator findings and queries.
• Identify OOS data trends to establish any systematic issues in process, testing, calibration or maintenance
• Implement plans to reduce and mitigate OOSs and enhance right first time performance.
• Perform impact and risk assessments of CAPA plans on process
• Implementation and development of improvement initiatives designed to increase lab productivity and customer services
• Provide analytical support to Aspen Group and AGI.
• Collaborate across Aspen sites to ensure growth and development within the QC Lab.
• Anticipate and critically evaluate scientific or regulatory advances and respond with appropriate new strategies.
• Keep up to date on latest developments within laboratory systems in order to understand how the applications can be further leveraged to meet business needs.
• Assist with improving analytical method development by implementing the concepts of lifecycle management and Quality by Design (QbD).

Requirements Background/experience

• Graduate Degree/ Diploma in Chemistry/ Analytical Chemistry with 10 to 15 years’ related experience.
• Experience in quantitative and instrumental analysis in QC and laboratory environment Specific job skills
• Extensive experience in scientific principles and laboratory techniques and methodologies
• Scientific report writing skills Understanding of pharmaceutical manufacturing, standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives
• Thorough knowledge of Pharmaceutical analytical issues, manufacturing processes and operations environment, including a detailed knowledge of validation, regulatory affairs, R&D, and new product transfer Competencies
• Information Interpretation
• Interrogating Information
• Offering Insights
• Investigating Possibilities
• Creating Clarity
• Navigating Complexity
• Problem Solving