Senior Officer, Documentation & GMP

Amneal Pharmaceuticals LLC; Hyderabad; On-site; INR 400,000 - 600,000; Full time

Job summary

A leading pharmaceutical company is looking for a qualified professional to take on multiple responsibilities in Quality Assurance activities within manufacturing operations in Hyderabad. The ideal candidate will be responsible for ensuring compliance with quality standards, batch release, and continuous monitoring of manufacturing processes. A commitment to diversity and inclusion is integral to the company culture.

Responsibilities

• Responsible for commercial batch release to market.
• Responsible for in process Quality Assurance activities.
• Responsible for In process Quality Assurance checks during Manufacturing, packing operations.
• Responsible for line clearance of manufacturing, Packing and dispensing activities.
• Responsible for assurance of cleaning, sterilization and aseptic manipulations of components.
• Responsible for Sampling of Cleaning Validation & Compilation of the records.
• Responsible for Sampling & compilation of Process Validation Reports (PVRs).
• Responsible for sampling and coordination during validation studies (process / cleaning validation).
• Responsible for routine monitoring of Manufacturing Areas.
• Good Documentation recording and updation.
• Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs).
• Responsible for the routine GMP Inspection & review of Quality Records of other departments.
• Responsible for monitoring in Aseptic process simulation study.
• Responsible for Preparation and Compilation of Media Fill Protocol, Report.
• Involve in Initiation of Change Control, Deviation and Participate in Failure Investigation.
• Responsible for environmental monitoring (Viable) in liquid, lyophilized and dry powder manufacturing areas.
• Responsible for preparation and implementation of SOP's.
• Viable monitoring in clean areas of manufacturing and warehouse as per the defined schedule.
• Responsible for personnel monitoring.
• Calibration certificate review and approval.

Job description

Responsibilities

• Responsible for commercial batch release to market
• Responsible for in process Quality Assurance activities.
• Responsible for In process Quality Assurance checks during Manufacturing, packing operations.
• Responsible for line clearance of manufacturing, Packing and dispensing activities
• Responsible for assurance of cleaning, sterilization and aseptic manipulations of components.
• Responsible for Sampling of Cleaning Validation & Compilation of the records.
• Responsible for Sampling & compilation of Process Validation Reports (PVRs)
• Responsible for sampling and coordination during validation studies (process / cleaning validation).
• Responsible for routine monitoring of Manufacturing Areas.
• Good Documentation recording and updation.
• Responsible for Review of Batch Manufacturing Record (BMR) & Batch Packing Records (BPRs).
• Responsible for the routine GMP Inspection & review of Quality Records of other departments.
• Responsible for monitoring in Aseptic process simulation study.
• Responsible for Preparation and Compilation of Media Fill Protocol, Report.
• Involve in Initiation of Change Control, Deviation and Participate in Failure Investigation.
• Responsibleforenvironmentalmonitoring(Viable)inliquid,lyophilizedanddrypowdermanufacturing areas
• Responsible for preparation and implementation of SOP's
• Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
• Responsible for personnel monitoring.
• Calibration certificate 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.

Job Info

• Job Identification 6679
• Job Category Manufacturing Process Operations
• Posting Date 10/29/2025, 05:11 AM
• Locations Plot No.- S/3, S/4 &S/5A, Hyderabad, AP, 509301, IN