Analytical Subject Matter Expert

2 weeks ago


East London, South Africa Aspen Pharma Group Full time

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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