JOB DESCRIPTION – QA EXECUTIVE
Company: Azentyx Health Care Pvt. Ltd.
Department: Quality Assurance (QA)
Designation: QA Executive
Location: Baddi, Himachal Pradesh
Reporting To: QA Manager / Head – Quality Assurance
Job Purpose
To support and maintain the Quality Assurance system by ensuring compliance with GMP, GLP, SOPs, regulatory requirements, and company quality standards. The QA Executive will be responsible for documentation, in-process quality oversight, deviation/CAPA management, audits, and continuous improvement of the Quality Management System.
Key Responsibilities
- Ensure compliance with GMP, cGMP, SOPs, and applicable regulatory requirements.
- Review and maintain Batch Manufacturing Records (BMR), Batch Packing Records (BPR), logbooks, SOPs, formats, and other QA documents.
- Perform line clearance and ensure proper documentation before and during manufacturing/packing activities.
- Monitor manufacturing and packing operations for compliance with approved procedures.
- Review and handle deviations, incidents, change controls, CAPA, OOS/OOT, and other quality-related events.
- Participate in internal audits, self-inspections, vendor audits, and regulatory inspections.
- Ensure proper implementation and periodic review of SOPs and Quality Management System procedures.
- Review and approve documents as per the defined QA authorization matrix.
- Monitor environmental monitoring, hygiene, sanitation, and GMP compliance in relevant areas.
- Coordinate with Production, QC, Engineering, Warehouse, R&D, and other departments for quality-related activities.
- Support product/batch release activities as per approved procedures and authorization.
- Maintain QA records and ensure proper document control, traceability, and data integrity.
- Support training programs related to GMP, SOPs, quality systems, and regulatory compliance.
- Identify quality risks and support implementation of appropriate corrective and preventive actions.
- Ensure proper handling of market complaints, product recalls, and quality investigations, wherever applicable.
- Prepare and maintain QA reports, trackers, and compliance records.
- Promote a strong quality culture and continuous improvement within the organization.
Required Qualifications
- B.Pharm / M.Pharm / B.Sc / M.Sc or relevant qualification in Pharmaceutical/Life Sciences.
- Relevant experience in QA/QMS within the pharmaceutical industry will be preferred.
- Good knowledge of GMP, cGMP, GDP, SOPs, documentation practices, and data integrity.
- Good communication, analytical, documentation, and problem-solving skills.
- Basic knowledge of MS Office (Word, Excel, PowerPoint).
Key Skills
- Quality Management System (QMS)
- GMP/cGMP Compliance
- Documentation & Data Integrity
- Deviation & CAPA
- Change Control
- Audit & Inspection Readiness
- Line Clearance
- Risk Assessment
- Investigation & Root Cause Analysis
- Cross-functional Coordination
Key Performance Indicators (KPIs)
- Timely closure of deviations, CAPA, and change controls.
- Compliance with GMP and internal quality standards.
- Accuracy and completeness of QA documentation.
- Audit and inspection compliance.
- Timely review of batch and quality records.
- Reduction in recurring quality issues.
- Effective implementation of QMS procedures.
Note: The responsibilities may be modified as per business requirements, applicable regulatory guidelines, and the organization's Quality Management System.
Pay: ₹15,000.00 - ₹35,000.00 per month
Benefits:
- Flexible schedule
- Food provided
- Leave encashment
- Life insurance
- Paid time off
- Provident Fund
Work Location: In person
