Assistant Manager, Quality Assurance

Amneal Pharmaceuticals

Hyderabad, India

8-10 Years

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Job Description

Description

JOB DESCRIPTION

Responsible for implementation of approved procedures and responsible for system and facility

compliance audits.

To conduct or be part of team conducting risk assessment of various activities, equipment, systems, etc.

in the location

Responsible for assessment and logging of Deviation, CAPA
To carry out investigations to the deviations, market complaints, OOS, OOTs, etc. by using appropriate

root cause analysis tools, assessing the risk associated with them and ensuring compliance of the non

conformances as per the cGMP by documenting it through the CAPA system.

To carry out self inspection activity as per Procedure
To prepare Quality management review report
To impart training on Mandatory training topics like cGMP, GDP etc.
To review updated guidelines and informs gaps in the current practices to respective department heads

and quality assurance head for its compliance.

To evaluate and respond to customer / regulatory queries / observation related to documents
Approval of document request forms received from various departments.
To prepare standard operating procedures of Quality Assurance Department and review the SOPs of

cross functional departments.

To handle the Quality risk management activities, follow-ups, status updation and approval of the QRMs.
To handle of Contract service agreement documentation activities, follow-ups, updation of status and

annual planner preparation.

To handle the vendor management activities. Review of vendor qualification documents and updation of

approved vendor list.

Responsible for review of material code creation request form.
To update the List of deactivating agents and deactivation procedure as per R & D recommendation.
Responsible to check production shop floor compliance.
To handle the changes carried out in the location by assessing the risk associated with it as per the

change control procedure.

To co-ordinate regulatory / customer audits conducted at the location, recording the day to day activities,

informing the same to the management, coordinate with respective department for online compliances (if

required) and provide the compliance to the audit observations by coordinating with respective

departments and guidance of the HOD within the stipulated timeline.

Responsible for initiation and Closing of Change Controls

Education

QUALIFICATIONS

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

Experience

8 years or more in 8 - 10 Years

Specialized Knowledge: Licenses:

More Info

Job Type:

Industry:

Function:

Employment Type:

About Company

Amneal PharmaceuticalsJob Source: www.linkedin.com

Job ID: 150676221

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Last Updated: 03-07-2026 10:12:39 PM

Homejobs in Hyderabad / Secunderabad, TelanganaAssistant Manager, Quality Assurance

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