1. Position OverviewThe 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 ResponsibilitiesA. 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
- 812 years of experience in QC within pharmaceutical, nutraceutical, or softgel manufacturing
- Minimum 35 years in a supervisory or managerial QC role
- Experience facing audits (FSSAI, WHO-GMP, customer audits)
- Hands-on experience with analytical instruments
