QA - Officer to Manager

5 days ago

halol, India Job Excel Full time

Responsibilities:

  • QAOfficer:

    • Execute qualityassurance activities as per standard operating procedures (SOPs)and regulatory requirements.
    • Conductroutine inspections and audits of manufacturing processesfacilities and documentation.
    • Assistin the investigation of deviations nonconformances and customercomplaints.
    • Support in theimplementation of corrective and preventive actions (CAPAs) toaddress quality issues.
    • Participatein the preparation and review of batch documentation and qualityrecords.

  • SeniorExecutive:

    • Oversee andcoordinate QA activities across multiple departments or productlines.
    • Provide guidance and supportto QA Officers in executing quality assurancetasks.
    • Review and approve batchdocumentation change controls and validationprotocols.
    • Lead investigations intocomplex quality incidents and ensure timelyresolution.
    • Contribute to thedevelopment and revision of quality policies procedures andguidelines.

  • AssistantManager:

    • Manage a team of QAprofessionals and allocate resources effectively to meetobjectives.
    • Develop and implementquality improvement initiatives to enhance processes andsystems.
    • Act as a subject matterexpert in regulatory requirements and industry bestpractices.
    • Represent the QAdepartment in internal and external audits regulatory inspectionsand client meetings.
    • Monitor keyperformance indicators (KPIs) to assess the effectiveness ofqualitysystems.

  • DeputyManager:

    • Provide strategicdirection and leadership in all aspects of quality assuranceactivities.
    • Drive continuousimprovement initiatives to optimize quality managementprocesses.
    • Collaborate withcrossfunctional teams to resolve complex quality issues andimplement preventivemeasures.
    • Mentor and coach juniorteam members to foster their professionaldevelopment.
    • Contribute to thedevelopment and execution of the companys quality strategy andobjectives.

  • Manager:

    • Overseethe overall quality management system and ensure compliance withregulatory standards.
    • Develop andmaintain strong relationships with regulatory authorities andindustry stakeholders.
    • Lead thepreparation and execution of regulatory submissions andinspections.
    • Drive a culture ofquality excellence throughout the organization through training andawareness programs.
    • Providestrategic insights and recommendations to senior management onqualityrelatedmatters.

Requirements

Qualifications:

  • Bachelorsor Masters degree in Pharmacy. Additional qualifications in QualityAssurance or Regulatory Affairs arepreferred.
  • Years of relevantexperience in the pharmaceutical industry with increasing levels ofresponsibility for higherpositions.
  • Sound knowledge of cGMP(current Good Manufacturing Practice) guidelines and regulatoryrequirements (e.g. USFDA ROW EU CDT EMAICH).
  • Strong analytical skills andattention to detail with the ability to identify and resolvequality issueseffectively.
  • Excellent communicationinterpersonal and leadership skills with the ability to collaborateacross functionalteams.
  • Certification in QualityManagement Systems (e.g. ISO 9001) and auditing techniques isdesirable for managerialroles.

Responsibilities: QA Officer: Execute quality assurance activitiesas per standard operating procedures (SOPs) and regulatoryrequirements. Conduct routine inspections and audits ofmanufacturing processes, facilities, and documentation. Assist inthe investigation of deviations, non-conformances, and customercomplaints. Support in the implementation of corrective andpreventive actions (CAPAs) to address quality issues. Participatein the preparation and review of batch documentation and qualityrecords. Senior Executive: Oversee and coordinate QA activitiesacross multiple departments or product lines. Provide guidance andsupport to QA Officers in executing quality assurance tasks. Reviewand approve batch documentation, change controls, and validationprotocols. Lead investigations into complex quality incidents andensure timely resolution. Contribute to the development andrevision of quality policies, procedures, and guidelines. AssistantManager: Manage a team of QA professionals and allocate resourceseffectively to meet objectives. Develop and implement qualityimprovement initiatives to enhance processes and systems. Act as asubject matter expert in regulatory requirements and industry bestpractices. Represent the QA department in internal and externalaudits, regulatory inspections, and client meetings. Monitor keyperformance indicators (KPIs) to assess the effectiveness ofquality systems. Deputy Manager: Provide strategic direction andleadership in all aspects of quality assurance activities. Drivecontinuous improvement initiatives to optimize quality managementprocesses. Collaborate with cross-functional teams to resolvecomplex quality issues and implement preventive measures. Mentorand coach junior team members to foster their professionaldevelopment. Contribute to the development and execution of thecompany's quality strategy and objectives. Manager: Oversee theoverall quality management system and ensure compliance withregulatory standards. Develop and maintain strong relationshipswith regulatory authorities and industry stakeholders. Lead thepreparation and execution of regulatory submissions andinspections. Drive a culture of quality excellence throughout theorganization through training and awareness programs. Providestrategic insights and recommendations to senior management onquality-related matters. Requirements Qualifications: Years ofrelevant experience in the pharmaceutical industry, with increasinglevels of responsibility for higher positions. Sound knowledge ofcGMP (current Good Manufacturing Practice) guidelines andregulatory requirements (e.g., USFDA, ROW, EU, EMA, ICH). Stronganalytical skills and attention to detail, with the ability toidentify and resolve quality issues effectively. Excellentcommunication, interpersonal, and leadership skills, with theability to collaborate across functional teams. Certification inQuality Management Systems (e.g., ISO 9001) and auditing techniquesis desirable for managerial roles.

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