QA Sr Executive

Drlogy; Vadodara; On-site; INR 500,000 - 800,000; Full time

Job summary

Drlogy in Vadodara is looking for a QA Sr. Executive to oversee quality assurance activities, ensuring compliance with GMP, GLP, and company standards. Key responsibilities include managing documentation review, performing line clearance checks, handling deviations, and supporting audits. The ideal candidate will have strong experience in quality assurance, regulatory compliance, and CAPA activities, contributing to continuous improvement in product quality. Join us to enhance operational efficiency and maintain high-quality standards.

Qualifications

• Strong understanding of GMP, GLP, and quality assurance standards.
• Experience in handling deviations, non-conformances, and CAPA activities.
• Ability to conduct audits and inspections.

Responsibilities

• Manage quality assurance activities including documentation review and in-process checks.
• Support audits, validations, and CAPA implementation.
• Ensure compliance with GMP and quality standards.

Job description

The QA Sr. Executive will be responsible for managing and monitoring quality assurance activities including documentation review, in-process checks, line clearance, deviation handling, and compliance with GMP standards. The involves supporting audits, validations, CAPA implementation, and continuous improvement initiatives while ensuring adherence to regulatory and organizational quality requirements.

• Monitor and ensure compliance with GMP, GLP, and company quality standards.
• Perform line clearance and in-process quality checks during manufacturing operations.
• Review batch manufacturing records, batch packing records, and quality documentation.
• Handle deviations, non-conformances, change controls, and CAPA activities.
• Ensure implementation and adherence to SOPs and quality procedures.
• Support process validation, cleaning validation, and equipment qualification activities.
• Conduct sampling and verification of raw materials, packaging materials, and finished products.
• Coordinate with production, QC, and regulatory teams for quality-related activities.
• Participate in internal audits, external audits, and regulatory inspections.
• Ensure timely closure of audit observations and compliance gaps.
• Maintain documentation control and ensure data integrity compliance.
• Support Annual Product Quality Review (APQR) activities.
• Monitor environmental conditions and ensure compliance with quality requirements.
• Ensure calibration and maintenance status of instruments and equipment.
• Investigate quality issues and support root cause analysis.
• Provide training and guidance to staff on quality systems and SOP compliance.
• Maintain accurate QA records, logs, and MIS reports.
• Ensure readiness of manufacturing and QA areas for inspections and audits.
• Support continuous improvement initiatives for enhancing product quality and operational efficiency.
• Stay updated with regulatory guidelines and industry best practices.