Company Overview
Role Purpose
Academic Stream
Work experience (in months)
Job Responsibility and key Decisions
Responsibilities
Execute physicochemical analytical methods to support manufacturing batches and product characterization.
Stay updated with all current applicable regulations and guidelines
Perform system suitability tests, data analysis, and documentation per GMP standards.
Assist in troubleshooting and investigation of analytical method issues.
Maintain and update analytical records, SOPs, and validation documents.
Collaborate with QC, MSAT, and manufacturing teams to ensure timely delivery of reliable analytical data.
Support quality audits and regulatory inspections by providing accurate documentation and data.
Key Decisions
Identify and escalate potential analytical issues or deviations promptly.
Decide when to seek assistance from senior MSAT or Quality personnel.
Recommend minor adjustments to analytical procedures under supervision.
Determine completeness and accuracy of documentation before submission.