Job Description

Key Responsibilities:
Continuous Process Verification (CPV):

• Collect, compile, and analyze process data from manufacturing batches.
• Monitor critical process parameters and quality attributes to ensure process consistency.
• Support trending and statistical analysis for process performance.
• Assist in identifying process deviations and recommending corrective actions.

Data Entry & Management:

• Ensure accurate and timely entry of process and quality data into designated systems (e.g., LIMS, SAP, Excel).
• Maintain data integrity and compliance with ALCOA+ principles.
• Generate periodic reports and dashboards for internal review.

Scientific Document Review:

• Review batch manufacturing records, SOPs, protocols, and technical reports for completeness and accuracy.
• Ensure documents meet regulatory and internal quality standards.
• Collaborate with cross-functional teams (QA, QC, MSAT) for document approvals and updates.