Assistant Manager QA-QMS

3 days ago

Karachi, Sindh, Pakistan Getz Pharma Full time $90,000 - $120,000 per year

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.

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