Officer QA Doc Cell

Amneal Pharmaceuticals LLC; Ahmedabad District; On-site; INR 300,000 - 420,000; Full time

Job summary

Amneal Pharmaceuticals LLC in India seeks a QA Documentation professional to support quality assurance documentation in pharmaceutical manufacturing. You will help define, maintain, and audit quality documentation per regulatory standards, while ensuring timely delivery of compliant products and effective document workflows.

The role requires at least 1 year of experience in QA documentation or related fields, with preference for B.Pharm / M.Pharm candidates, and involves collaboration with

Qualifications

• Education: B.Pharm / M.Pharm preferred.
• Experience: 1 year or more.
• Internal postings require minimum 2 years in current role.

Responsibilities

• Define and specify quality activities and standards for documentation management per cGMP.
• Maintain quality documentation infrastructure to ensure timely, compliant products.
• Audit and monitor documentation processes and outputs against internal and regulatory standards.
• Maintain efficient workflows, procedures, policies, and inspection programs within the QA documentation cell.
• Support in-process quality monitoring and vendor quality interactions.
• Report and troubleshoot manufacturing process deviations and documentation defects.
• Compile APQR reports and ensure compliance with 21 CFR Part 210 and 211.
• Support change control and deviation management under senior guidance.
• Participate in complaints and recalls and implement CAPAs.

Skills

Quality documentation

Auditing

Stakeholder communication

cGMP compliance

Education

B.Pharm / M.Pharm (preferred)

Job description

Job Description:

Description

JOB DESCRIPTION

This role supports the quality assurance documentation cell 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 manufacturing processes and documentation outputs against defined internal and regulatory standards. It supports the maintenance of efficient and effective workflows, procedures, policies, and inspection programs within the QA documentation cell 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 documentation defects. This role provides structured exposure to pharmaceutical quality documentation practices and regulatory compliance requirements within the Indian pharmaceutical manufacturing context.

Essential Functions

• Assist in defining and specifying quality activities, processes, and standards for quality documentation management in pharmaceutical manufacturing in accordance with cGMP requirements
• Support the maintenance of quality documentation infrastructure and systems to ensure timely delivery of compliant pharmaceutical products
• Participate in auditing and monitoring documentation processes and manufacturing outputs against defined internal and regulatory standards
• Assist in maintaining efficient workflows, procedures, policies, and inspection programs within the QA documentation cell 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 documentation-related defects
• 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 / M. Pharm - Preferred

Experience: 1 year or more

Note: Candidates who want to apply for internal job posting for must have completed min. 2 years in existing role.

Requirements: