Analytical QA

2 weeks ago

halol, India Job Excel Full time

Responsibilities:

  • AnalyticalQA Officer:

    • Executeanalytical quality assurance activities as per standard operatingprocedures (SOPs) and regulatoryrequirements.
    • Perform review andapproval of analytical test methods validation protocols andreports.
    • Conduct audits andinspections of analytical laboratories to ensure compliance withcGMP regulations.
    • Assist ininvestigations of analytical deviations and outofspecificationresults.
    • Support in theimplementation of corrective and preventive actions (CAPAs) relatedto analyticaltesting.

  • SeniorExecutive:

    • Overseeanalytical QA activities and provide guidance to the team inensuring data integrity andcompliance.
    • Review and approveanalytical method validation and transfer protocols andreports.
    • Lead investigations intocomplex analytical issues and deviations ensuring timelyresolution.
    • Collaborate withcrossfunctional teams to address analytical challenges and optimizeprocesses.
    • Participate in regulatoryinspections and provide support during audits of analyticallaboratories.

  • AssistantManager:

    • Manage a team ofanalytical QA professionals and coordinate their activities to meetquality objectives.
    • Develop andimplement strategies to enhance analytical quality systems andimprove efficiency.
    • Serve as asubject matter expert in analytical method validation equipmentqualification and laboratorycompliance.
    • Lead continuousimprovement initiatives to streamline analytical processes andenhance data integrity.
    • Providetraining and mentorship to junior staff members to foster theirprofessionalgrowth.

Requirements

Qualifications:

  • Bachelorsor Masters degree in Pharmacy. Additional qualifications inAnalytical Chemistry or Quality Assurance arepreferred.
  • Years ofrelevant experience in analytical quality assurance within thepharmaceutical industry.
  • Thoroughunderstanding of analytical techniques instrumentation andvalidation principles.
  • Proficiencyin regulatory requirements (e.g.USFDA ROW EU EMACTD ICH) and cGMP guidelines related toanalyticaltesting.
  • Stronganalytical skills attention to detail and ability to troubleshootanalytical issueseffectively.
  • Excellent communicationleadership and teamwork skills with a proactive approach toproblemsolving.

Responsibilities: Analytical QA Officer: Execute analytical qualityassurance activities as per standard operating procedures (SOPs)and regulatory requirements. Perform review and approval ofanalytical test methods, validation protocols, and reports. Conductaudits and inspections of analytical laboratories to ensurecompliance with cGMP regulations. Assist in investigations ofanalytical deviations and out-of-specification results. Support inthe implementation of corrective and preventive actions (CAPAs)related to analytical testing. Senior Executive: Oversee analyticalQA activities and provide guidance to the team in ensuring dataintegrity and compliance. Review and approve analytical methodvalidation and transfer protocols and reports. Lead investigationsinto complex analytical issues and deviations, ensuring timelyresolution. Collaborate with cross-functional teams to addressanalytical challenges and optimize processes. Participate inregulatory inspections and provide support during audits ofanalytical laboratories. Assistant Manager: Manage a team ofanalytical QA professionals and coordinate their activities to meetquality objectives. Develop and implement strategies to enhanceanalytical quality systems and improve efficiency. Serve as asubject matter expert in analytical method validation, equipmentqualification, and laboratory compliance. Lead continuousimprovement initiatives to streamline analytical processes andenhance data integrity. Provide training and mentorship to juniorstaff members to foster their professional growth. RequirementsQualifications: Years of relevant experience in analytical qualityassurance within the pharmaceutical industry. Thoroughunderstanding of analytical techniques, instrumentation, andvalidation principles. Proficiency in regulatory requirements(e.g.,USFDA, ROW, EU, EMA, CTD,, ICH) and cGMP guidelines relatedto analytical testing. Strong analytical skills, attention todetail, and ability to troubleshoot analytical issues effectively.Excellent communication, leadership, and teamwork skills, with aproactive approach to problem-solving.

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