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Assistant Manager, QC Investigation at Amneal India
, , India -
Full Time

Start Date

Immediate

Expiry Date

06 Oct, 26

Salary

0.0

Posted On

08 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

QC Investigation, Root Cause Analysis, CAPA Implementation, Data Integrity, GMP Compliance, GLP Compliance, OOS Investigation, OOT Investigation, Trend Analysis, Analytical Data Interpretation, Regulatory Readiness, Audit Monitoring

Industry

Pharmaceutical Manufacturing

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  
Responsibilities
Responsible for conducting in-process and final product quality investigations, including OOS, OOT, and deviations, to ensure compliance with global regulatory standards. The role involves interpreting analytical data, performing root cause analysis, and implementing CAPAs to prevent production risks.