Description

JOB DESCRIPTION

The role is responsible for ensuring in-process and final product quality analyses in compliance with regulatory standards and internal specifications. The role focuses on interpreting and evaluating analytical results for accuracy and precision against established criteria. The role involves identifying recurring quality issues, preventing potential production risks, and recommending continuous improvement actions. The position uses validated testing equipment, measuring devices, and prescribed methods to accept or reject materials and products. As a people leader, the role audits and monitors manufacturing processes, oversees random testing of finished goods, and ensures timely reporting of deviations and defects to maintain product quality and compliance.

Essential Functions

Oversee in-process and finished product quality control testing activities
Interpret analytical results against approved specifications and standards
Identify quality trends, deviations, and potential production risks
Ensure acceptance or rejection of materials and products based on test results
Audit and monitor manufacturing processes for quality compliance
Review and approve analytical data, reports, and COA documentation
Lead investigation of deviations, defects, and non-conformances
Ensure compliance with GMP, GLP, and regulatory requirements
Manage and develop QC team performance and competency
Support internal and external audits and regulatory inspections
Drive continuous improvement initiatives within QC operations
Build team capability through Training and Competency Management

Additional Responsibilities

QUALIFICATIONS

Education

Master Degree (MS/MA) M. Sc. - Required
M. Pharm M. Pharm - Preferred

Experience:

12 years or more in 12 - 15 Years

Specialized Knowledge: Licenses:

Manager-Quality

Deputy Manager, Quality Control