QA Manager

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:

• Bachelor's (Required)

Experience:

• Managerial Profile: 3 years (Required)

Work Location: In person