job description - Analytical Subject Matter Expert (SME)
- 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
Report
About the company
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Aspen Pharma Group is a global specialty and branded pharmaceutical company, that improves the health of patients across the world through our high-quality and affordable medicines.
