Quality Assurance Officer

Drlogy; Surendranagar; On-site; INR 300,000 - 600,000; Full time

Job summary

Drlogy seeks a Quality Assurance Officer in Surendranagar, India. Responsible for ensuring GMP compliance and supporting quality systems in a pharmaceutical facility. The role involves documenting accuracies, conducting routine checks, and coordinating QA activities with various teams.

The ideal candidate will have a strong understanding of QA practices, SOPs, and regulatory guidelines, with the ability to handle deviations and support internal audits effectively.

Qualifications

• Strong knowledge of GMP compliance and documentation accuracy.
• Experience in coordinating with production, QC, warehouse, and engineering teams.
• Ability to support audits and inspections.

Responsibilities

• Review batch manufacturing records for completeness.
• Ensure compliance with GMP and internal quality standards.
• Conduct routine shop-floor checks.
• Handle documentation related to deviations and CAPA.
• Support internal and regulatory audits.

Skills

Knowledge of QA practices

SOPs understanding

Regulatory guidelines knowledge

Deviation handling

CAPA knowledge

Data integrity

Job description

The Quality Assurance Officer will be responsible for ensuring GMP compliance, documentation accuracy, batch record review, shop‑floor monitoring, and quality system support in a pharmaceutical manufacturing facility. This requires strong knowledge of QA practices, SOPs, regulatory guidelines, deviation handling, CAPA, and data integrity. The candidate will coordinate with production, QC, warehouse, and engineering teams to maintain product quality, compliance, and audit readiness.

• Review batch manufacturing records, batch packing records, logbooks, and quality documents for completeness.
• Ensure compliance with GMP, SOPs, regulatory guidelines, and internal quality standards.
• Conduct routine shop‑floor checks in production, packing, warehouse, and quality areas.
• Support line clearance, in‑process checks, and process compliance verification activities.
• Handle documentation related to deviations, CAPA, change control, incidents, and investigations.
• Monitor closure of quality observations, pending actions, and compliance trackers.
• Coordinate with production, QC, warehouse, engineering, and regulatory teams for QA‑related activities.
• Maintain controlled documents, issuance records, retrieval logs, and archival documentation.
• Verify cleaning records, equipment status, material status, and area readiness when required.
• Identify documentation gaps, procedural non‑compliances, and quality risks for timely correction.
• Support internal audits, customer audits, regulatory inspections, and inspection readiness activities.
• Ensure data integrity, traceability, and timely completion of QA documentation.
• Review SOPs, validation records, qualification documents, protocols, and reports when assigned.
• Train staff on GMP, documentation practices, and quality requirements.
• Promote a strong quality culture through continuous monitoring and adherence to approved procedures.