Description
Description:
The position is responsible for in-process and final product quality investigations in compliance with internal standards and global regulatory requirements. The role focuses on interpreting analytical and microbiological data for accuracy and precision against approved specifications.The role involves identifying recurring quality issues, investigating OOS, OOT, deviations, and trends, and preventing potential production and product quality risks. The role audits and monitors manufacturing outputs using validated methods, instruments, and predefined specifications to accept or reject materials and finished goods. The role ensures robust documentation, regulatory readiness, and continuous improvement, while supporting corrective and preventive actions to enhance overall quality performance.
Essential Functions:
Perform detailed QC investigations for OOS, OOT, deviations, and atypical results
Interpret and evaluate in-process, finished product,
and stability data against specifications
Review analytical data, audit trails, and laboratory documentation for data integrity
Identify ongoing and potential quality issues and recommend preventive measures
Execute root cause analysis and ensure timely CAPA implementation
Audit and monitor QC outputs for compliance
Support acceptance or rejection decisions for RM, PM, IP, and FG samples
Ensure regulatory compliance with GMP, GLP, and pharmacopoeial requirements
Trend quality data to detect systemic risks and process variability
Support internal and external audits and inspections
Qualifications
Education:
B. Pharm B. Pharm - Required
M. Pharm M. Pharm - Preferred