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    Analytical QA - halol, India - Job Excel

    Job Excel
    Job Excel halol, India

    2 days ago

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    Description

    Responsibilities:

    • Analytical QA Officer:
      • Execute analytical quality assurance activities as per standard operating procedures (SOPs) and regulatory requirements.
      • Perform review and approval of analytical test methods, validation protocols, and reports.
      • Conduct audits and inspections of analytical laboratories to ensure compliance with cGMP regulations.
      • Assist in investigations of analytical deviations and out-of-specification results.
      • Support in the implementation of corrective and preventive actions (CAPAs) related to analytical testing.
    • Senior Executive:
      • Oversee analytical QA activities and provide guidance to the team in ensuring data integrity and compliance.
      • Review and approve analytical method validation and transfer protocols and reports.
      • Lead investigations into complex analytical issues and deviations, ensuring timely resolution.
      • Collaborate with cross-functional teams to address analytical challenges and optimize processes.
      • Participate in regulatory inspections and provide support during audits of analytical laboratories.
    • Assistant Manager:
      • Manage a team of analytical QA professionals and coordinate their activities to meet quality objectives.
      • Develop and implement strategies to enhance analytical quality systems and improve efficiency.
      • Serve as a subject matter expert in analytical method validation, equipment qualification, and laboratory compliance.
      • Lead continuous improvement initiatives to streamline analytical processes and enhance data integrity.
      • Provide training and mentorship to junior staff members to foster their professional growth.
    Requirements

    Qualifications:

    • Bachelor's or Master's degree in Pharmacy. Additional qualifications in Analytical Chemistry or Quality Assurance are preferred.
    • Years of relevant experience in analytical quality assurance within the pharmaceutical industry.
    • Thorough understanding of analytical techniques, instrumentation, and validation principles.
    • Proficiency in regulatory requirements (e.g.,USFDA, ROW, EU, EMA, CTD,, ICH) and cGMP guidelines related to analytical testing.
    • Strong analytical skills, attention to detail, and ability to troubleshoot analytical issues effectively.
    • Excellent communication, leadership, and teamwork skills, with a proactive approach to problem-solving.
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