QA Executive

Puniska Injectables Pvt. Ltd.; North Goa; On-site; INR 600,000 - 900,000; Full time

Job summary

Puniska Injectables Pvt. Ltd. is seeking a Quality Assurance professional to ensure GMP, IPQA, and regulatory compliance across pharmaceutical manufacturing and packing operations.

The role focuses on batch documentation, investigations, and quality system activities to maintain product quality and compliance. The incumbent will perform IPQA activities, conduct line clearance, review batch records, handle deviations and CAPA, and coordinate change controls and audits with cross-functional teams,

Qualifications

• Ensure quality, GMP and regulatory compliance across pharma manufacturing and packing.
• Handle IPQA, batch documentation, quality system compliance and investigations.

Responsibilities

• Perform IPQA activities and ensure GMP compliance on the shop floor.
• Conduct line clearance and verify manufacturing/packing activities as per procedures.
• Review BMR/BPR, logbooks and other batch-related documents.
• Handle deviations, incidents, OOS/OOT investigations and CAPA.
• Review and coordinate Change Controls and quality actions.
• Ensure SOPs, GDP and data integrity compliance.
• Support internal, customer and regulatory audits.
• Coordinate QA-related training and maintain training records.
• Participate in validation, qualification and quality risk management.
• Monitor audit observations and CAPA closure.
• Coordinate with Production, QC, Engineering and other departments for issue resolution.
• Ensure timely QA documentation and quality system activities.

Skills

IPQA

GMP compliance

QA documentation

CAPA handling

Change Controls

Regulatory compliance

Audit coordination

Data integrity

Line clearance

Cross-functional coordination

Job description

Job Summary

Responsible for ensuring quality, GMP and regulatory compliance across pharmaceutical manufacturing and packing operations. The role involves IPQA, batch documentation, quality system compliance, investigation of quality events and coordination with cross-functional teams to maintain product quality and compliance.

Roles & Responsibilities

• Perform IPQA activities and ensure GMP compliance on the shop floor.
• Conduct line clearance and verify manufacturing/packing activities as per approved procedures.
• Review BMR/BPR, logbooks and other batch-related documents.
• Handle deviations, incidents, OOS/OOT investigations and CAPA.
• Review and coordinate Change Controls and quality-related actions.
• Ensure compliance with SOPs, GDP and data integrity requirements.
• Support internal, customer and regulatory audits.
• Coordinate QA-related training and maintain training records.
• Participate in validation, qualification and quality risk management activities.
• Monitor and follow up on audit observations and CAPA closure.
• Coordinate with Production, QC, Engineering and other departments for resolution of quality issues.
• Ensure timely completion of QA documentation and quality system activities.