Assistant Manager QA-QMS

Job Responsibilities: Initiate, assess, and manage change controls related to facilities, equipment, materials, processes, documents, and systems. Ensure proper risk assessment, impact analysis, and timely closure of change controls in compliance with ICH Q10 and WHO guidelines. Liaise with cross-functional departments to evaluate proposed changes and ensure adequate controls are in place. Oversee the logging, classification, and evaluation of deviations from approved processes and procedures. Lead cross-functional teams in conducting thorough root cause analysis (RCA) using scientific tools and methodologies. Ensure deviations are investigated, documented, and closed within defined timelines, with appropriate corrective and preventive actions.

Ensure CAPAs are properly identified, implemented, tracked, and verified for effectiveness. Monitor trends in deviations, complaints, and audit findings to proactively identify areas for improvement. Facilitate CAPA boards or review meetings and maintain compliance with ICH Q10 principles of pharmaceutical quality systems. Apply systematic problem-solving tools such as 5 Whys, Ishikawa diagrams, etc. to identify true root causes. Train and mentor staff in effective RCA practices to strengthen the culture of quality and compliance. Conduct and review risk assessments (as per ICH Q9) to support decision-making for deviations, changes, and CAPAs. Implement risk mitigation strategies and monitor effectiveness over time.

Support development and periodic review of risk management plans for critical processes and systems. Review completed batch manufacturing records (BMRs), quality control results, and associated documentation for compliance. Ensure that only conforming products are released, and that batch release meets applicable regulatory and internal quality standards. Ensure adherence to Good Documentation Practices (GDP) and review of SOPs, protocols, and reports. Support document control activities and ensure that controlled documents are maintained, revised, and distributed appropriately. Participate in data integrity initiatives and ensure records are attributable, legible, contemporaneous, original, and accurate (ALCOA+).

Prepare and present QMS-related data and documents during internal audits and external inspections. Assist in timely closure of audit findings and implementation of sustainable improvements. Promote a culture of continuous improvement within the QA-QMS team. Identify trends and systemic issues using QMS metrics and propose preventive strategies. Conduct QMS training for site personnel to enhance compliance awareness. Required Experience, Knowledge & SkillsMaster’s degree in Chemistry, Applied Chemistry, Pharmaceutical Sciences (Pharm-D), or a related field. 6-8 years of experience in Quality Assurance & Compliance in a pharmaceutical manufacturing environment.

In-depth knowledge of WHO GMP, ICH Q8, Q9, Q10, and other applicable global regulatory standards. Strong working knowledge of investigation techniques, CAPA effectiveness checks, and compliance management. Hands-on experience with QMS software tools and electronic documentation systems is preferred. Excellent analytical, communication, and documentation skills. Ability to work independently and collaboratively in a fast-paced environment. Detail-oriented with a strong compliance and continuous improvement mindset.