Officer, Quality Control

Amneal Pharmaceuticals LLC

Ahmedabad District

Presencial

INR 300.000 - 600.000

Jornada completa

Hace 3 días
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Descripción de la vacante

Amneal Pharmaceuticals LLC seeks a QC Analyst to conduct in-process and final product quality analyses in a GMP/GDP environment. You will interpret results, operate precision measuring devices, and ensure conformance to internal and regulatory standards across finished goods testing.

With 1–4 years in a quality control role, you will document activities and support CAPA implementations while adhering to Indian and international pharma regulations. This position is based in Ahmedabad, India.

Formación

  • B. Pharm or B. Pharm/M.Sc is required.
  • 1–4 years of experience in QC department.

Responsabilidades

  • Perform in-process and final product quality analysis and inspections in compliance with regulatory and internal standards.
  • Interpret and evaluate analytical results for accuracy and precision against established specifications.
  • Operate measuring devices and testing equipment following predetermined methods to accept or reject products.
  • Test random samples of finished goods to verify conformance with quality specifications.
  • Report manufacturing deviations and defects to relevant stakeholders.
  • Identify ongoing quality issues and recommend preventive measures to avoid production problems.
  • Maintain accurate documentation of all testing activities in line with GDP and GMP.

Conocimientos

Quality analysis
Regulatory compliance
Analytical testing

Educación

B. Pharm
M.Sc

Herramientas

Measuring devices
Testing equipment

Descripción del empleo

JOB DESCRIPTION

This role is responsible for conducting in-process and final product quality analyses and inspections in strict compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates analytical results in terms of accuracy and precision against predefined specifications to ensure product integrity. Various measuring devices, testing equipment, and predetermined methods are employed to accept or reject products based on prescribed specifications. The role contributes to identifying ongoing quality issues and preventing potential production problems through proactive monitoring and timely escalation. Manufacturing process deviations and defects in finished goods are identified, documented, and reported in accordance with Good Manufacturing Practices. Random samples of finished goods are tested to verify conformance with internal and regulatory quality standards. The position supports continuous improvement initiatives by suggesting enhancements to testing methods and quality processes. It operates within a structured quality management framework aligned with 21 CFR Part 210 and 211, ICH guidelines, and applicable Indian and international pharmaceutical regulations.

Essential Functions
  • Perform in-process and final product quality analysis and inspections in compliance with regulatory and internal standards
  • Interpret and evaluate analytical results for accuracy and precision against established specifications
  • Operate measuring devices, testing equipment, and follow predetermined methods to accept or reject products
  • Test random samples of finished goods to verify conformance with quality specifications
  • Report manufacturing process deviations and defects in finished goods to relevant stakeholders
  • Identify ongoing quality issues and recommend preventive measures to avoid potential production problems
  • Maintain accurate and complete documentation of all testing activities in accordance with GDP and GMP requirements
  • Support implementation of corrective and preventive actions arising from quality investigations
Qualifications

Education: B. Pharm B. Pharm/ M.Sc - Required
Experience: 1 to 4 Years in QC department
Specialized Knowledge: Licenses:

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