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 & Skills

• Master’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.