Senior Executive, QA Validation

Amneal India; Gujarat; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal India is seeking a experienced professional for Qualification and Validation across equipment, systems, facilities and utilities in sterile injectable manufacturing environments.

The role focuses on initiating and reviewing validation protocols, executing lifecycle activities (URS to PQ), and ensuring compliance with regulatory standards. Strong collaboration with manufacturing, engineering, QC and QA is essential.

Qualifications

• M.Sc./ B.Pharm/ M.Pharm with minimum 7–9 years of relevant experience
• Hands-on experience in Qualification/Validation function within an injectable pharmaceutical manufacturing environment

Responsibilities

• Prepare and review Validation/Qualification protocols and reports (IOQ, PQ, RQ, CQ, and other qualification documents).
• Execute Qualification / Re-Qualification and Validation activities for Equipment, System, Facility and utilities.
• Coordinate with manufacturing, Engineering, Material Management, QC and other users for qualification/validation activities.
• Prepare and review SOPs of Validation and Quality Assurance Department.
• Establish, monitor and maintain Validation function for audit readiness.
• Complete Validation Lifecycle: URS, DQ, FAT, SAT, IQ, OQ, PQ.
• Assess Change Control, Deviation, CAPA and participate in investigations.
• Prepare, review and execute risk assessment activity related to equipment/process/facility/system.

Skills

Data Integrity

Documentation Security

Documentation & Record Control

Equipment Qualification Oversight

Process Validation Master Plan

Quality Risk Analysis & Control

Regulatory Compliance

Validation & Qualification Oversight

Validation Protocol Implementation

Validation Reporting

Education

M.Sc./ B.Pharm/ M.Pharm

Job description

To prepare and review of URS, DQ, QRM, FAT, SAT, and vendor/ supplier’s documents related to qualification.

To execute Qualification / Re-Qualification and Validation activities of Equipment / System / Facility and Plant utilities (HVAC system, Autoclave, Isolator, Filling machine, Washing machine, Depyrogenation tunnel, UAFs, Packaging equipment, Water system, Pure steam generation and distribution system, Nitrogen/compressed air distribution system etc.).

To perform qualification activities like air flow visualization study, Temperature mapping of Rooms/Chambers, Packaging validation, Transport validation etc.

To co-ordinate with manufacturing, Engineering, Material Management, QC personnel and other users for respective Qualification / Validation / Re-qualification activities for timely completion of activities.

To prepare and review Validation/ Qualification protocols and reports (IOQ, PQ, RQ, CQ, other miscellaneous qualification documents etc).

To prepare and review process validation, cleaning validation, media fill and hold time study protocols and reports.

To prepare and review of SOPs of Validation and Quality Assurance Department.

To prepare and update Annual Validation Planner.

To prepare and execute project validation master plan for commissioning and qualification of new/modified facility.

To assess Change Control, Deviation, CAPA etc. and participate in investigation triggered through deviation, OOS, OOT or other failures.

To involved in QMS related activities i.e initiation and review of QMS elements.

To prepare, review and execute risk assessment activity related to equipment/ process/ facility/ system.

To conduct sampling activities as per the protocols (Hold time, Process validation and cleaning validation etc.).

Establish, monitor and maintain Validation function for audit readiness.

To prepare VMP and SMF.

To implement contamination control strategy at site.

Complete Validation Lifecycle: URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ

End-to-end validation lifecycle (URS, DQ, FAT, SAT, Commissioning, IQ, OQ, PQ)

Qualification of equipment, utilities, and facilities in sterile injectable manufacturing environments

Process validation and cleaning validation including protocol and report preparation

Thermal validation systems and temperature mapping studies

Media fill validation principles and execution

Basic risk assessment techniques (FMEA approach)

Validation documentation management and report compilation

Use of validation management software and electronic documentation systems

Coordination and management of end-to-end qualification/validation activities

Qualifications

M.Sc./ B.Pharm/ M.Pharm with minimum 7–9 years of relevant experience

Hands-on experience in Qualification/Validation function within an injectable pharmaceutical manufacturing environment

Required Skills

• Data Integrity & Documentation Security
• Documentation & Record Control
• Equipment Qualification Oversight
• Process Validation Master Plan
• Quality Risk Analysis & Control
• Regulatory Compliance
• Validation & Qualification Oversight
• Validation Protocol Implementation
• Validation Reporting

Job Info

• Job Identification 8303
• Job Category Quality Assurance
• Posting Date 09/10/2026, 12:24 PM
• Locations Survey number 253,255,256,257, GJ, IN