Analytical Subject Matter Expert
2 weeks ago
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
**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.
? 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
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