Key Responsibilities
- Lead and manage the complete Quality Assurance function across the organization.
- Develop, implement, and continuously improve the Quality Management System (QMS).
- Ensure compliance with WHO-GMP, Schedule M, ISO, USFDA/EU-GMP, and applicable regulatory requirements.
- Oversee internal audits, external audits, customer audits, and regulatory inspections.
- Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), SOPs, Specifications, Validation Protocols, and Quality Documents.
- Manage Change Control, CAPA, Deviations, OOS investigations, and risk assessments.
- Oversee qualification and validation activities, including equipment, process, cleaning, and analytical method validation.
- Review and authorize product release in accordance with quality standards.
- Lead vendor qualification, supplier audits, and quality agreements.
- Ensure compliance with Data Integrity (ALCOA+) principles and documentation practices.
- Coordinate with Production, QC, Regulatory Affairs, R&D, Purchase, and Warehouse for effective quality management.
- Drive continuous improvement initiatives and promote a strong quality culture across the organization.
- Lead, mentor, and develop the Quality Assurance team to achieve departmental objectives.
Required Skills
- Complete Quality Management System (QMS) Implementation & Maintenance
- Regulatory Compliance & Documentation
- Internal & External Audit Management
- Validation Oversight (Process, Cleaning, Equipment & Analytical Methods)
- Risk Management & Quality Risk Assessment
- Vendor Qualification & Supplier Audits
- Change Control Management
- CAPA & Deviation Management
- Product Release Authorization
- Regulatory Inspection Management
- Data Integrity Governance (ALCOA+)
- Strategic Quality Planning
- Team Leadership & Performance Management
- Strong Communication, Decision-Making & Problem-Solving Skills
- Proficiency in MS Office and ERP/QMS Software
Preferred Candidate Profile
- Strong leadership and managerial capabilities.
- Excellent knowledge of pharmaceutical and cosmetic quality regulations.
- Detail-oriented with exceptional documentation and analytical skills.
- Ability to manage multiple quality projects and regulatory commitments simultaneously.
- Proactive, disciplined, and committed to continuous quality improvement.
Pay: ₹15,000.00 - ₹50,000.00 per month
Benefits:
- Cell phone reimbursement
- Health insurance
- Internet reimbursement
- Leave encashment
- Paid time off
- Provident Fund
Application Question(s):
- Do you have B.Pharma + 7 Years of Experience?
- Do you have M.Pharma + 5 Years of Experience?
- Do you have Manufacturing Plant (In-House Production) Experience?
Education:
Experience:
- Managerial Profile: 3 years (Required)
Work Location: In person
