Senior Executive, QA Validation

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Ahmedabad, Gujarat, India, seeks a qualified professional to lead qualification and validation activities for equipment, systems, and plant utilities in sterile injectable manufacturing environments.

You will prepare and review qualification protocols and reports, coordinate with cross-functional teams, and ensure compliance with QMS and regulatory requirements throughout the validation lifecycle.

Qualifications

• Hands-on experience in Qualification/Validation in injectable pharmaceutical manufacturing.
• Experience with URS, DQ, FAT, SAT, IQ/OQ/PQ lifecycle.
• Knowledge of cleaning validation and media fill practices.
• Familiarity with QMS, CAPA, deviations and change controls.

Responsibilities

• Prepare and review qualification/validation protocols and reports.
• Coordinate with Manufacturing, Engineering, QA, QC for timely completion of activities.
• Conduct sampling, cleaning validation and process validation per approved plans.
• Establish and maintain validation lifecycle documentation and audit readiness.

Skills

Data Integrity

Documentation Security

Record Control

Equipment Qualification

Process Validation

Quality Risk Analysis

Regulatory Compliance

Documentation Writing

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