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Analytical Subject Matter Expert

1 month 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 and 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).

**Skills Required**:
***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