Head of Quality Assurance

1. Position Overview

Quality Assurance, Quality Control, Documentation, Compliance, and Regulatory alignment

2. Key Responsibilities

A. Quality Leadership & Strategy

• Define and implement the company-wide quality strategy and QMS.
• Ensure alignment with regulatory guidelines (FSSAI, WHO-GMP, AYUSH, PIC/S where applicable).
• Drive a culture of quality, accountability, and continuous improvement across all departments.

B. Quality Assurance (QA) Oversight

• Oversee batch documentation review, BMR/BPR approval, and batch release.
• Manage change controls, deviations, CAPA, OOS/OOT investigations, and risk assessments.
• Ensure implementation of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
• Approve and monitor SOPs, quality policies, and QMS updates.

C. Quality Control (QC) Oversight

• Supervise QC operations including raw material, in-process, and finished product testing.
• Ensure all laboratory activities follow GLP and data integrity compliance.
• Approve specifications, COAs, analytical methods, and stability data.
• Ensure calibration, qualification, and maintenance of all analytical instruments.

D. Regulatory Compliance & Audit Management

• Ensure compliance with national and international regulatory requirements.
• Lead internal audits and face external audits from regulatory authorities, certifying bodies, and clients.
• Ensure timely submission of regulatory documents, renewals, and certifications.
• Maintain audit-readiness and ensure closure of observations within stipulated timelines.

E. Documentation Control & Data Integrity

• Oversee the document control system including SOPs, master documents, and controlled records.
• Ensure strong data integrity practices across QA, QC, Production, and Warehousing.
• Approve master manufacturing and packing records.

F. Cross-Functional Collaboration

• Work closely with Production, R&D, Procurement, Warehousing, and Engineering to ensure end-to-end quality compliance.
• Provide technical support in vendor qualification and raw material evaluation.
• Participate in product development, scale-up, and technology transfer activities.

G. Team Leadership & Development

• Lead, mentor, and develop teams within QA, QC, and compliance functions.
• Define departmental KPIs and monitor performance.
• Ensure continual training and competency improvement for all QA/QC staff.

3. Skills & Competencies

• Deep knowledge of GMP, GLP, GDP, and quality systems.
• Strong understanding of nutraceutical/pharmaceutical manufacturing (especially softgel operations).
• Proven experience in facing audits (FSSAI, WHO-GMP, customer audits).
• Excellent leadership, communication, and cross-functional management skills.
• Strong analytical, problem-solving, and decision-making abilities.
• Expertise in documentation, risk management, and CAPA systems.

4. Qualifications & Experience

• Master’s or Bachelor’s degree in Pharmacy, Chemistry, Life Sciences, or related field.

• 10–15+ years

   of experience in Quality roles within pharmaceutical or nutraceutical manufacturing.

• Minimum 5 years

   in a senior managerial / head-level quality position.
• Experience handling regulatory inspections and customer audits.
• Strong exposure to QMS design, QA/QC operations, and compliance management.