Key Responsibilities
- Develop, implement, and maintain the Quality Assurance system in compliance with AYUSH, GMP, GLP, and applicable regulatory guidelines.
- Review and approve Standard Operating Procedures (SOPs), Batch Manufacturing Records (BMRs), Batch Packaging Records (BPRs), specifications, protocols, and validation documents.
- Approve or reject raw materials, packaging materials, in-process materials, and finished products based on quality standards.
- Monitor manufacturing activities to ensure adherence to approved procedures and quality standards.
- Handle deviations, change controls, non-conformances, Out-of-Specification (OOS) investigations, CAPA, and risk assessments.
- Plan and conduct internal quality audits and ensure timely closure of audit observations.
- Coordinate regulatory inspections and customer audits, ensuring compliance with all observations.
- Review and monitor validation and qualification activities, including process validation, cleaning validation, equipment qualification, and utility validation.
- Oversee stability studies,



product quality reviews (PQR/APQR), and annual quality assessments.
- Ensure proper documentation practices (GDP) and data integrity across all quality records.
- Investigate customer complaints and coordinate product recalls whenever required.
- Lead, mentor, and develop QA personnel through regular training and performance evaluations.
- Coordinate with Production, QC, R&D;, Purchase, Warehouse, and Regulatory Affairs for quality-related activities.
- Ensure calibration schedules, environmental monitoring, and sanitation programs are effectively implemented.
- Drive continuous improvement initiatives to enhance product quality, compliance, and operational efficiency.

Qualification
- Bachelor’s or Master’s degree in Pharmacy (B.Pharm/M.Pharm), Ayurveda (BAMS), Chemistry, Microbiology.
- Additional certification in GMP, Quality Management, or Regulatory Affairs will be an added advantage.

Experience
- 4–6 ye

📌 QA Manager (Por)
🏢 VITAL CRAE
📍 Por