24 Aug
|
AZENTYX HEALTHCARE
|
Baddi
24 Aug
AZENTYX HEALTHCARE
Baddi
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
📌 QA Executive (Baddi)
🏢 AZENTYX HEALTHCARE
📍 Baddi