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Executive, Quality Assurance
full-timeHyderabad

Summary

Location

Hyderabad

Type

full-time

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About this role

Job Responsibility

•Responsible for routine monitoring of Manufacturing Areas.

•Responsible for the routine GMP Inspection & review of Quality Records of other departments.

•To monitor and ensure compliance level of organization is as per current GMP requirement

•Good Documentation recording and updation.

•Responsible for review of URS, DQ and vendor / suppliers documents related to qualification.

•Responsible for preparation of Validation / Qualification protocol and report.

•Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities.

•Responsible for adequacy of execution of validations being carried out at prescribed procedures.

•Responsible for assurance of calibrations before performing qualifications.

•Responsible to co-ordinate with cross functional department personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.

•Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.

•Responsible to check production shop floor compliance.

•Responsible for preparation and review of VMP.

•Responsible for preparation, review, execution data and compilation updation of validation related documents.

•Responsible for handling of failures during qualification by using QMS tools.

•Responsible for Preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System.

•Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.

•Responsible for personnel monitoring.

•Responsible to participate in qualification, requalification, area qualification activities.

•Calibration certification review and approval

                  


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.

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.


Other facts

Tech stack
GMP Compliance,Documentation,Validation Protocols,Quality Records Review,Cross-Functional Coordination,Risk Assessment,Calibration,Standard Operating Procedures,Personnel Monitoring,Manufacturing Area Monitoring,Quality Assurance,Failure Handling,Vendor Qualification,Execution Review,Clean Area Monitoring,Re-Qualification

About Amneal

Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver.

Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions.

Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam.

Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or [email protected]. If you are currently experiencing a life-threatening event, please immediately contact 911.

Team size: 5,001-10,000 employees
LinkedIn: Visit
Industry: Pharmaceutical Manufacturing
Founding Year: 2002

What you'll do

  • The Executive in Quality Assurance is responsible for monitoring manufacturing areas and ensuring compliance with GMP requirements. They will also prepare and review validation protocols, manage quality records, and coordinate with cross-functional teams for timely completion of qualification activities.

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Frequently Asked Questions

What does a Executive, Quality Assurance do at Amneal?

As a Executive, Quality Assurance at Amneal, you will: the Executive in Quality Assurance is responsible for monitoring manufacturing areas and ensuring compliance with GMP requirements. They will also prepare and review validation protocols, manage quality records, and coordinate with cross-functional teams for timely completion of qualification activities..

Why join Amneal as a Executive, Quality Assurance?

Amneal is a leading Pharmaceutical Manufacturing company.

Is the Executive, Quality Assurance position at Amneal remote?

The Executive, Quality Assurance position at Amneal is based in Hyderabad, India. Contact the company through Clera for specific work arrangement details.

How do I apply for the Executive, Quality Assurance position at Amneal?

You can apply for the Executive, Quality Assurance position at Amneal directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process. You can also learn more about Amneal on their website.