Executive, QC Testing

Amneal Pharmaceuticals

Description

JOB DESCRIPTION

This role is responsible for conducting quality testing activities on pharmaceutical products in compliance with established standards and regulatory requirements within a global pharmaceutical manufacturing environment. The incumbent interprets and evaluates testing results in terms of accuracy and precision against predetermined specifications to ensure product integrity and regulatory compliance. The position identifies ongoing quality issues and takes proactive measures to prevent potential production problems, contributing to continuous quality improvement. It applies various measuring devices, testing equipment, and prescribed methodologies to accept or reject products based on defined quality criteria. The role audits and monitors testing processes and outputs against both internal and regulatory standards to uphold compliance. It tests random samples of finished goods to verify conformance with quality specifications and regulatory expectations. The position reports testing process deviations and defects in finished goods to the appropriate quality and production stakeholders. It supports the organization's commitment to delivering safe, effective, and compliant pharmaceutical products through rigorous quality testing.

Essential Functions

  • Perform quality testing activities on pharmaceutical products in accordance with established specifications and regulatory requirements.
  • Interpret and evaluate testing results for accuracy and precision against predetermined quality standards.
  • Identify ongoing quality issues and implement preventive measures to avoid potential production disruptions.
  • Operate various measuring devices and testing equipment using predetermined methods and prescribed specifications to accept or reject products.
  • Audit and monitor testing processes and outputs against defined internal and regulatory quality standards.
  • Test random samples of finished goods to verify compliance with quality specifications.
  • Report testing process deviations and defects in finished goods to relevant stakeholders in a timely manner.
  • Contribute to process improvement initiatives by identifying opportunities to enhance quality testing processes and methodologies.
  • Maintain accurate and complete documentation of all quality testing activities in compliance with GMP and GLP requirements.

Additional Responsibilities

QUALIFICATIONS

Education

  • B. Pharm B. Pharm - Required
  • M. Pharm M. Pharm - Preferred

Experience:

  • 5 years or more in 5 - 8 Years

Specialized Knowledge: Licenses:

About Us

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

About The Team

The Human Resources team partners with all aspects of the organization, driving success through the effective and innovative management of people for both current and future business needs.

Key Roles That The Human Resources Team Performs

Executive Role: Specialists in all aspects of people management. High-level input at strategic level into all key business decisions.

Audit Role: Ensures all areas of the organization are compliant with legal requirements AND best practice employment policies and procedures.

Facilitator Role: Close partnership to support, advise and extend the ability of all areas of the organization to meet their objectives through implementation of highly effective employment practices in areas such as Talent Acquisition, Learning and Development, Reward systems, Performance Management, Health and Wellbeing.

Consultancy Role: Provide expert advice to the organization and it’s managers on any aspect of workforce management and employee relations and performance.

Service Role: Ensure the organization is fully aware of and is equipped to deal with developments impacting employment matters, such as changes in legislation, changes in the characteristics of the labor market.

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