About the role

The ideal candidate should have strong exposure to Pharma, Biopharma, or Medical Device industries with deep expertise in Quality Assurance, Quality Control, and regulatory compliance frameworks. Candidates from a polymer manufacturing background (Moulding, LSR, Extrusion) will have an added advantage.

Quick Summary:
• Role: AGM/GM – QA & QC (Head – Quality)
• Department: Quality (QA & QC)
• Location: Silvassa
• Experience: 14+ years
• Budget: ₹20 – 30 LPA

Job Overview:
The Head – Quality will lead the complete Quality function, ensuring stringent compliance with Pharma, Biopharma, and Medical Device regulatory standards. The role will oversee QA, QC, Audits, Validations, Compliances, Qualifications, Documentation, MIS, and Continual Improvement (CI) across all polymer-based manufacturing technologies.

Key Responsibilities:

A. Quality Assurance (QA)
• Develop and implement QMS aligned with ISO 9001, 13485, 15378
• Drive SOPs, validations, CAPA, deviation management, and risk assessment
• Ensure compliance with GMP, GDP, and customer standards

B. Quality Control (QC)
• Lead QC lab operations for RM, in-process, and finished goods
• Ensure calibration/validation of testing equipment
• Approve test methods and analytical data

C. Audits & Compliance
• Lead internal, customer, and certification audits
• Ensure readiness for ISO 9001, 14001, 45001, 13485, 27001 & 15378
• Liaise with auditors, regulatory bodies, and customers

D. Validation & Qualification
• Oversee IQ/OQ/PQ, process and equipment validation
• Ensure qualification of facilities, cleanrooms, and manufacturing processes

E. MIS & Reporting
• Publish monthly dashboards (CAPA, complaints, rejection %, audit status)
• Track and report KPIs to management

F. Continual Improvement (CI)
• Implement Lean, Kaizen, 5S, Six Sigma initiatives
• Drive reduction in rejection, rework, and complaints

G. Leadership & Team Development
• Build and lead a high-performing QA & QC team
• Conduct GMP, quality culture, and compliance trainings

Key Skills & Competencies:
• Strong expertise in QA, QC, QMS, and regulatory compliance
• Knowledge of ISO standards and GMP practices
• Experience in validations, risk assessment (FMEA), and audits
• Leadership, analytical thinking, and stakeholder management

KPIs:
• Reduction in complaints, rejection %, and deviations
• CAPA closure effectiveness
• Audit success rate and compliance readiness
• Improvement in RFT and quality clearance timelines
• CI impact and team development metrics