Senior Quality Assurance Associate

Drlogy; Jammu district; On-site; INR 600,000 - 900,000; Full time

Job summary

Drlogy is seeking a Senior Quality Assurance Associate in India, Jammu and Kashmir. The position entails managing QA activities including batch record review, deviation handling, CAPA follow-up, and ensuring compliance with GMP standards.

The ideal candidate must possess strong pharmaceutical QA experience, regulatory understanding, and excellent communication skills. Responsibilities include supporting internal audits, monitoring GMP compliance, and guiding junior team members in QA practices.

Qualifications

• Strong pharmaceutical QA experience is essential for the role.
• The candidate must possess a solid understanding of regulatory requirements.
• Investigative skills are required for deviation handling and CAPA follow-up.

Responsibilities

• Review and approve batch manufacturing records and QA documentation.
• Monitor GMP compliance across various areas.
• Support internal audits and regulatory inspections.

Skills

Pharmaceutical QA experience

Regulatory understanding

Investigation skills

Cross-functional coordination

GMP compliance monitoring

Job description

The Senior Quality Assurance Associate will be responsible for managing advanced QA activities, including batch record review, deviation handling, CAPA follow-up, audit readiness, documentation control, and GMP compliance monitoring. This requires strong pharmaceutical QA experience, regulatory understanding, investigation skills, and cross-functional coordination. The candidate will support quality system effectiveness, guide junior team members, and ensure all manufacturing and packing operations meet approved quality standards.

• Review and approve batch manufacturing records, batch packing records, and QA documentation.
• Monitor GMP compliance across production, packing, warehouse, engineering, and quality areas.
• Lead or support investigations for deviations, incidents, complaints, OOS, and process non-compliances.
• Track CAPA implementation and verify effectiveness of corrective and preventive actions.
• Coordinate change control activities and ensure proper documentation of quality system changes.
• Conduct routine shop-floor audits, process checks, and documentation compliance reviews.
• Support internal audits, customer audits, regulatory inspections, and inspection readiness programs.
• Review SOPs, validation documents, qualification records, protocols, and technical reports when required.
• Guide junior QA staff on documentation practices, GMP requirements, and compliance expectations.
• Coordinate with production, QC, warehouse, engineering, and regulatory teams for quality decisions.
• Identify recurring quality issues and recommend process improvement actions.
• Ensure controlled document management, record archival, and data integrity compliance.
• Prepare quality trend reports, audit observations, CAPA summaries, and management updates.
• Support training programs related to GMP, SOPs, quality systems, and regulatory compliance.
• Strengthen quality culture by ensuring consistent adherence to approved procedures and standards.