Role & responsibilities

QMS & GMP Compliance, Deviations, OOS/OOT & CAPA, Change Control Management, Market Complaints, Root Cause Analysis, Risk Assessment

Preferred candidate profile

- Management of Quality Management System (QMS) activities.
- Review and approval of Deviations, OOS, OOT, and Incident investigations.
- CAPA initiation, effectiveness verification, and lifecycle management.
- Change Control assessment, review, and implementation.
- Handling and investigation of Market Complaints and Product Quality Complaints.
- Preparation, review, and approval of SOPs, specifications, protocols, and reports.
- Internal audits, self-inspections, and compliance monitoring.
- Vendor qualification and quality agreement management.
- Quality Risk Management (QRM) using tools such as FMEA and risk assessment matrices.
- Management Review meetings and quality metrics trending.
- Regulatory inspection readiness and response management.
- Data integrity compliance and GMP documentation review.
- Training management and effectiveness evaluation.
- Support for product quality reviews (PQR/APQR).
- Continuous improvement initiatives and quality culture enhancement.

📌 Assistant Manager - Quality Assurance (Baddi)
🏢 Venus Remedies (VRL)
📍 Baddi