Officer, IPQA

Amneal Pharmaceuticals; Ahmedabad District; On-site; INR 500,000 - 800,000; Full time

Job summary

Amneal Pharmaceuticals in India is seeking an IPQA professional to support in-process quality assurance within a pharmaceutical manufacturing setting. You will help define quality activities, assist audits, and maintain documentation to meet regulatory standards.

The role requires a B.Pharm (M.Pharm preferred) with 2–5 years of IPQA experience, strong knowledge of cGMP, and the ability to liaise with stakeholders to resolve quality issues.

Qualifications

• Bachelor of Pharmacy is required, Master’s degree preferred.
• 2–5 years of experience in IPQA or in-process quality assurance.
• Familiarity with cGMP and regulatory standards relevant to pharmaceutical manufacturing.

Responsibilities

• Assist in defining quality activities, processes, and standards for IPQA in pharmaceutical manufacturing.
• Participate in auditing and monitoring in-process activities and outputs against internal and regulatory standards.
• Support maintenance of workflows, procedures, and inspection programs within IPQA.
• Assist in compiling APQR reports and maintaining quality documentation per 21 CFR Part 210/211 guidance.
• Support change control, deviation management, and CAPA activities under supervision.
• Contribute to reporting and resolving manufacturing deviations and quality-related issues with stakeholders.

Skills

Quality assurance

Auditing

Regulatory compliance

Documentation

Communication

Education

B.Pharm

M.Pharm

Job description

JOB DESCRIPTION

This role supports the in-process quality assurance function within a pharmaceutical manufacturing environment, contributing to the definition and specification of activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products. The incumbent assists in building and maintaining the infrastructure and systems necessary to ensure the timely delivery of quality products in compliance with applicable regulatory standards. The role participates in auditing, monitoring, and determining the quality of in-process manufacturing activities and outputs against defined internal and regulatory standards. It supports the maintenance of efficient and effective workflows, procedures, policies, and inspection programs within the IPQA framework. The position assists in managing in-process product quality activities and communicates with relevant stakeholders in resolving quality-related issues. It contributes to reporting and troubleshooting manufacturing process deviations and defects in finished goods. This role provides structured exposure to pharmaceutical in-process quality assurance practices and regulatory compliance requirements within the Indian pharmaceutical manufacturing context.

Description

This role supports the in-process quality assurance function within a pharmaceutical manufacturing environment, contributing to the definition and specification of activities, processes, and standards required to fulfill quality requirements for manufactured materials, components, and products. The incumbent assists in building and maintaining the infrastructure and systems necessary to ensure the timely delivery of quality products in compliance with applicable regulatory standards. The role participates in auditing, monitoring, and determining the quality of in-process manufacturing activities and outputs against defined internal and regulatory standards. It supports the maintenance of efficient and effective workflows, procedures, policies, and inspection programs within the IPQA framework. The position assists in managing in-process product quality activities and communicates with relevant stakeholders in resolving quality-related issues. It contributes to reporting and troubleshooting manufacturing process deviations and defects in finished goods. This role provides structured exposure to pharmaceutical in-process quality assurance practices and regulatory compliance requirements within the Indian pharmaceutical manufacturing context.

Essential Functions

• Assist in defining and specifying quality activities, processes, and standards for in-process quality assurance in pharmaceutical manufacturing in accordance with cGMP requirements
• Support the maintenance of quality infrastructure and systems to ensure timely delivery of compliant pharmaceutical products
• Participate in auditing and monitoring in-process manufacturing activities and outputs against defined internal and regulatory standards
• Assist in maintaining efficient workflows, procedures, policies, and inspection programs within the IPQA function
• Support in-process quality monitoring activities and assist in managing quality-related interactions with vendors
• Contribute to reporting and troubleshooting manufacturing process deviations and defects in finished goods
• Assist in compiling APQR reports and maintaining quality documentation in compliance with 21 CFR Part 210 and 211
• Support change control and deviation management processes under the guidance of senior quality personnel
• Participate in complaint and recall assessment activities and contribute to corrective and preventive action implementation

Additional Responsibilities

QUALIFICATIONS

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 2 years or more in 2 - 5 Years

Specialized Knowledge:

Licenses: