Head of Quality Assurance

Briyosis Soft Caps Pvt. Ltd.; Vadodara; On-site; INR 12,00,000 - 18,00,000; Full time

Job summary

A nutraceutical manufacturing company is seeking a Head of Quality to establish and maintain the Quality Management System (QMS). Responsible for quality assurance, control, and compliance, this role requires leadership, regulatory expertise, and strategic thinking. The ideal candidate will have a Master’s or Bachelor’s degree in a relevant field and substantial experience in quality roles. This position ensures all products meet applicable standards and drives continuous improvement across departments.

Qualifications

• 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.

Responsibilities

• Define and implement the company-wide quality strategy and QMS.
• Oversee batch documentation review and batch release.
• Ensure compliance with national and international regulatory requirements.

Skills

GMP knowledge

GLP understanding

Quality systems expertise

Cross-functional management skills

Analytical problem-solving

Education

Master’s or Bachelor’s degree in Pharmacy, Chemistry, Life Sciences

Job description

Position Overview

The Head of Quality is responsible for establishing, implementing, and maintaining the overall Quality Management System (QMS) at Briyosis. This role oversees Quality Assurance, Quality Control, Documentation, Compliance, and Regulatory alignment, ensuring that all products meet applicable standards and that the organization remains audit‑ready at all times. The position requires strong leadership, regulatory expertise, and strategic thinking to drive continuous improvement and uphold the highest levels of GMP.

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.

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.

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.