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QA Executive (cGMP Compliance)
QA Executive (cGMP Compliance)
22
Ahmedabad
Job Views:
Created Date: 2026-01-12T12:00:00.354Z
Experience: 3 - year
Salary: upto
Industry: 28
Openings: 1
Primary Responsibilities :
Job Title:
QA Executive (cGMP Compliance)
Department: Quality Assurance
Reporting To: Owner
Location: Kalol, Ahmedabad
Experience: 3–7 Years (cGMP-regulated environment)
Role Purpose
To independently manage and ensure full compliance with cGMP, quality systems, documentation, and regulatory standards for pharmaceutical and chemical manufacturing operations.
Experience Requirement
3–7 years hands-on QA experience in a cGMP-regulated manufacturing facility
Experience in independent QA handling is mandatory
Preferred Industry Exposure
Pharmaceutical manufacturing
API / Intermediates
Excipients / Chemical manufacturing
WHO-GMP / ISO certified plants
Experience Requirements:
Key Responsibilities
1. cGMP & Quality System Management
Ensure compliance with cGMP, GLP, GDP and regulatory standards (IP, BP, USP, WHO, ISO).
Independently handle QA activities related to manufacturing, packing, testing, and batch release.
Establish, implement, and maintain the Quality Management System (QMS).
2. Documentation & Compliance
Prepare, review, approve, and control:
SOPs, STPs, BMRs, BPRs
Specifications, protocols, and formats
Change control, deviation, OOS, and OOT documents
Ensure data integrity and Good Documentation Practices (GDP).
3. Batch Release & QA Oversight
Review batch manufacturing and packing records.
Provide QA clearance for batch release.
Monitor compliance during manufacturing and packaging operations.
4. Deviations, CAPA & Risk Management
Handle deviations and incidents independently.
Perform Root Cause Analysis (RCA).
Implement and verify CAPA effectiveness.
Conduct risk assessments and trend analysis.
5. Validation & Qualification
Coordinate and review:
Process validation
Equipment qualification (DQ, IQ, OQ, PQ)
Cleaning validation
Ensure timely and compliant execution of validation activities.
6. Audit & Inspection Handling
Conduct internal audits and vendor audits.
Independently handle:
Regulatory inspections
Customer audits
Prepare audit responses and compliance reports.
7. Training & Compliance Culture
Conduct cGMP training for Production, QC, and Warehouse teams.
Promote and ensure implementation of quality policies.
8. Regulatory & Customer Coordination
Support regulatory submissions and compliance documentation.
Handle customer complaints, investigations, and responses.
Educational Qualification
B.Pharm / M.Pharm / M.Sc (Chemistry) / B.Sc / Chemical Engineering
Certification in Quality / GMP / ISO preferred
Key Skills & Competencies
Strong knowledge of cGMP, QMS, IP/BP/USP standards
Ability to work independently
Excellent documentation and compliance skills
Strong analytical and problem-solving ability
Good communication and audit-handling skills