Head of Quality Control

1. Position Overview

The QC Head is responsible for leading and managing all Quality Control activities at Briyosis. This includes oversight of raw material, in-process, and finished product testing; ensuring compliance with regulatory standards; maintaining laboratory systems; and supporting continuous improvement in product quality and GMP practices.

2. Key Responsibilities

A. Quality Control Operations

• Oversee the testing of raw materials, packing materials, bulk products, and finished products as per approved specifications.
• Ensure timely release of batches and materials through efficient sample management and coordination with production & QA.
• Approve COAs, analytical reports, and ensure accuracy of test results.

B. Laboratory Management

• Supervise daily operations of the QC laboratory including chemical, instrumental, and microbiology sections (if applicable).
• Ensure calibration, qualification, and maintenance of instruments such as HPLC, UV, GC, IR, dissolution testers, etc.
• Implement and maintain Good Laboratory Practices (GLP).

C. Compliance & Documentation

• Ensure compliance with GMP, FSSAI, AYUSH, WHO-GMP, PIC/S, and other applicable standards.
• Review and approve SOPs, STPs, test methods, and specifications.
• Ensure proper documentation control including data integrity, logbooks, and electronic records.

D. Regulatory & Audit Readiness

• Lead QC-related activities during regulatory inspections, customer audits, and internal audits.
• Coordinate OOS, OOT, deviations, CAPA, and investigation reports.
• Ensure analytical method validation and verification as required.

E. Team Leadership

• Manage, train, and develop the QC team (analysts, chemists, microbiologists).
• Allocate responsibilities, oversee performance, and ensure continual skill enhancement.
• Maintain discipline, safety, and hygiene standards in the lab.

F. Cross-Functional Coordination

• Work closely with QA, Production, R&D, Procurement, and Stores for smooth quality operations.
• Provide technical support during vendor qualification and raw material evaluation.
• Participate in change control, risk assessment, and process improvement initiatives.

3. Skills & Competencies

• Strong knowledge of analytical techniques (HPLC, UV, GC, etc.)
• Excellent understanding of GMP, FSSAI, WHO-GMP, PIC/S standards
• Expertise in OOS/OOT handling and analytical investigations
• Leadership, communication, and team-building abilities
• Problem-solving and decision-making skills
• Ability to manage documentation systems and data integrity requirements

4. Qualifications & Experience

• Bachelor’s or Master’s degree in Chemistry, Pharmaceutical Sciences, or related field
• 8–12 years of experience in QC within pharmaceutical, nutraceutical, or softgel manufacturing
• Minimum 3–5 years in a supervisory or managerial QC role
• Experience facing audits (FSSAI, WHO-GMP, customer audits)
• Hands-on experience with analytical instruments