Senior Executive, QMS (QA)

Amneal Pharmaceuticals LLC; Gujarat; On-site; INR 900,000 - 1,800,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Gujarat seeks an experienced Quality Assurance professional to lead QMS activities and ensure cGMP compliance. You will manage CAPA and deviations, investigate OOS/OOT events, and drive change control processes across the site.

You will prepare APQR/APR, review SOPs and test procedures, and support Self-Inspection with a focus on data integrity and GDP. Vendor qualification and internal audits will also be part of your remit.

Qualifications

• CAPA, Deviation, Change Control requirements.
• Data Integrity & Documentation Security expectations.
• GST/ GDP and GMP compliant documentation practices.

Responsibilities

• Manage overall activity of QMS and implement quality systems to comply with cGMP.
• Handle Product Complaint, Deviation, OOS, OOT, Incident and Change Control.
• Review SOPs, instrument operating procedures and test procedures; ensure effective SOP implementation.
• Oversee Self-Inspection and APQR/APR proceedings; trend quality parameters.
• Coordinate recall investigations and corrective actions across the organization.
• Develop and execute risk assessments; coordinate with internal/external audit groups.
• Vendor Qualification and re-approval audits for RM, packaging materials, contract labs/services.

Skills

CAPA & Deviation Oversight

Change Control Documentation

Data Integrity & Documentation

Document Control & Governance

GDP & Documentation Practices

Audit Execution & Inspection

Investigation of Quality Issues

QMS Administration

Quality Risk Analysis

eQMS Review & Compliance

Education

B. Pharm / M. Pharm

Job description

• Managing overall activity of QMS. Establishing and implementing quality systems to comply cGMP. Handling of Product Complaint, Deviation, OOS (Out of Specification), OOT (Out of Trend), Incident and Change Control.
• CAPA management, tracking, verification of implemented CAPA from CCN, Deviation, OOS, Self-Inspection and Market complaint.
• Review of SOPs, Instrument operating procedure, standard test procedure, effective implementation of SOP.
• Handling of Self-Inspection.
• Annual Product Quality Review (APQR/APR) preparation and review, trending of quality parameter.
• Handling of Recall and Investigation of the same.
• Develop and execute risk assessments and reviews of compliance risk areas to determine need for improvement often in consultation and coordination with internal and external audit groups.
• Vendor Qualification: Handling the Vendor Qualification and Re-approval audit for RM (Raw Material), PPM (Primary Packaging Material), SPM (Secondary Packaging Material), Contract analysis laboratory and Contract services

Qualifications

Education: B. Pharm / M. Pharm

Experience: 5 - 8 Years

Note: Interested candidates who wants to apply for internal job posting must have completed minimum 2 years in their existing job role.

Required Skills

• CAPA & Deviation Oversight
• Change Control Documentation
• Data Integrity & Documentation Security
• Document Control & Governance
• Documentation & Record Control
• Good Documentation Practices (GDP)
• Internal & External Audit Execution
• Investigation of Quality Issues (OOS, OOAL, Deviations)
• Quality Management System
• Quality Management System Administration
• Quality Risk Analysis & Control
• eQMS Review & Compliance

Job Info

• Job Identification 8583
• Job Category Quality Assurance
• Locations Survey No. 168/1/1, Sanand, Gujarat, IN