Analytical QA

2 weeks ago

india Job Excel Full time
Job 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.

Requirements
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: 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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