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    QA - Officer to Manager - Halol, India - Job Excel

    Job Excel
    Job Excel Halol, India

    4 days ago

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    Description

    Responsibilities:

    1. QA Officer:
      • Execute quality assurance activities as per standard operating procedures (SOPs) and regulatory requirements.
      • Conduct routine inspections and audits of manufacturing processes, facilities, and documentation.
      • Assist in the investigation of deviations, non-conformances, and customer complaints.
      • Support in the implementation of corrective and preventive actions (CAPAs) to address quality issues.
      • Participate in the preparation and review of batch documentation and quality records.
    2. Senior Executive:
      • Oversee and coordinate QA activities across multiple departments or product lines.
      • Provide guidance and support to QA Officers in executing quality assurance tasks.
      • Review and approve batch documentation, change controls, and validation protocols.
      • Lead investigations into complex quality incidents and ensure timely resolution.
      • Contribute to the development and revision of quality policies, procedures, and guidelines.
    3. Assistant Manager:
      • Manage a team of QA professionals and allocate resources effectively to meet objectives.
      • Develop and implement quality improvement initiatives to enhance processes and systems.
      • Act as a subject matter expert in regulatory requirements and industry best practices.
      • Represent the QA department in internal and external audits, regulatory inspections, and client meetings.
      • Monitor key performance indicators (KPIs) to assess the effectiveness of quality systems.
    4. Deputy Manager:
      • Provide strategic direction and leadership in all aspects of quality assurance activities.
      • Drive continuous improvement initiatives to optimize quality management processes.
      • Collaborate with cross-functional teams to resolve complex quality issues and implement preventive measures.
      • Mentor and coach junior team members to foster their professional development.
      • Contribute to the development and execution of the company's quality strategy and objectives.
    5. Manager:
      • Oversee the overall quality management system and ensure compliance with regulatory standards.
      • Develop and maintain strong relationships with regulatory authorities and industry stakeholders.
      • Lead the preparation and execution of regulatory submissions and inspections.
      • Drive a culture of quality excellence throughout the organization through training and awareness programs.
      • Provide strategic insights and recommendations to senior management on quality-related matters.

    Requirements

    Qualifications:

    • Bachelor's or Master's degree in Pharmacy. Additional qualifications in Quality Assurance or Regulatory Affairs are preferred.
    • Years of relevant experience in the pharmaceutical industry, with increasing levels of responsibility for higher positions.
    • Sound knowledge of cGMP (current Good Manufacturing Practice) guidelines and regulatory requirements (e.g., USFDA, ROW, EU, CDT, EMA, ICH).
    • Strong analytical skills and attention to detail, with the ability to identify and resolve quality issues effectively.
    • Excellent communication, interpersonal, and leadership skills, with the ability to collaborate across functional teams.
    • Certification in Quality Management Systems (e.g., ISO 9001) and auditing techniques is desirable for managerial roles.

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