Head of Quality Assurance

Job Description

As the Head of Quality at Briyosis, your primary responsibility is to establish, implement, and maintain the Quality Management System (QMS). You will oversee Quality Assurance, Quality Control, Documentation, Compliance, and Regulatory alignment to ensure all products meet applicable standards and the organization remains audit-ready. Your role requires strong leadership, regulatory expertise, and strategic thinking to drive continuous improvement and uphold the highest levels of Good Manufacturing Practices (GMP).- Define and implement the company-wide quality strategy and QMS.- Ensure alignment with regulatory guidelines such as FSSAI, WHO-GMP, AYUSH, and PIC/S where applicable.- Drive a culture of quality, accountability, and continuous improvement.- Oversee batch documentation review, BMR/BPR approval, and batch release.- Manage change controls, deviations, CAPA, OOS/OOT investigations, and risk assessments.- Approve and monitor SOPs, quality policies, and QMS updates.- 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.- 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.- Oversee the document control system including SOPs, master documents, and controlled records.- Ensure strong data integrity practices across QA, QC, Production, and Warehousing.- Work closely with Production, R&D, Procurement, Warehousing, and Engineering to ensure end-to-end quality compliance.- 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.Deep knowledge of GMP, GLP, GDP, and quality systems will be essential for this role. You should also possess a strong understanding of nutraceutical/pharmaceutical manufacturing, especially softgel operations. Proven experience in facing audits, excellent leadership, communication, and cross-functional management skills, as well as strong analytical, problem-solving, and decision-making abilities, are crucial. Expertise in documentation, risk management, and CAPA systems will also be required.Qualifications & Experience:- Masters or Bachelors 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. As the Head of Quality at Briyosis, your primary responsibility is to establish, implement, and maintain the Quality Management System (QMS). You will oversee Quality Assurance, Quality Control, Documentation, Compliance, and Regulatory alignment to ensure all products meet applicable standards and the organization remains audit-ready. Your role requires strong leadership, regulatory expertise, and strategic thinking to drive continuous improvement and uphold the highest levels of Good Manufacturing Practices (GMP).- Define and implement the company-wide quality strategy and QMS.- Ensure alignment with regulatory guidelines such as FSSAI, WHO-GMP, AYUSH, and PIC/S where applicable.- Drive a culture of quality, accountability, and continuous improvement.- Oversee batch documentation review, BMR/BPR approval, and batch release.- Manage change controls, deviations, CAPA, OOS/OOT investigations, and risk assessments.- Approve and monitor SOPs, quality policies, and QMS updates.- 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.- 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.- Oversee the document control system including SOPs, master documents, and controlled records.- Ensure strong data integrity practices across QA, QC, Production, and Warehousing.- Work closely with Production, R&D, Procurement, Warehousing, and Engineering to ensure end-to-end quality compliance.- Lead, mentor, and develop teams within QA, QC, and compliance functions.- Define d

Keyskills :
GMPGLPleadershipcommunicationmanagementanalyticaldocumentationrisk managementGDPnutraceuticalpharmaceutical manufacturingsoftgel operationsauditsproblemsolvingdecisionmaking