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    QA Complaint Handling Associate - Selangor, Malaysia - Alcon

    Alcon
    Alcon Selangor, Malaysia

    Found in: Talent MY C2 - 3 days ago

    Default job background
    Full time
    Description

    Responsible for day-to-day case management of quality technical and adverse event complaint records, including intake, follow up, triage, system entry- and final response, involving Alcon devices, pharmaceutical products and OTC products. Complaints handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives

  • Ensure compliance of the regional/country complaint handling process for all Alcon products, including intake, follow up and triage for reports of quality/technical complaints and Adverse Events in compliance with local and international regulations, guidelines and applicable directives.
  • Receive initial complaint from any source (ECPs, patients, internal Alcon personnel) and assure all information/data is accurately captured at point of contact
  • Maintain an understanding of information or date required to be collected of technical and AE complaints to assure compliance with regulations and directives
  • Manage technical and adverse event complaint records for assigned areas using designated safety systems
  • Review potential complaint data received via safety systems and other methods as required
  • Perform intake/follow up/data entry activities and attached corresponding source documents in a timely manner per requirements and directives.
  • Perform all necessary reconciliation activities including for all customer-oriented programs in accordance with procedures
  • Triage/address calls from all sources for quality technical complaints, Adverse Events, and assist into the request for refund, request for replacement product and requests for credit
  • Adheres to require metrics for all complaint intake responsibilities
  • Arrange for replacement, product return and shipping of samples to QA side for analysis
  • Closes files according to establish guidelines to meet required timelines
  • Maintain a working knowledge of company policies and procedures, departmental processes, and associated work instructions
  • Monitor the evolving local and international regulations, guidelines, and applicable directives, and inform regional/ global of the changes in a timely manner
  • Alcon products for assigned therapeutic areas and corresponding documentation (Product Insets, DFUs, Manuals, Promotional Materials)
  • Support, collaborate and ensure Country inspection readiness (internal and/or external). Support for and close out of audits, corrective plan, investigation, related to vigilance. Proactive identify compliance issues and compliance gaps, follow up and closure of observations in close cooperation with regional and global.
  • Responsible country(ies): South Korea, Taiwan and China

    • Key Performance Indicators (KPI)

  • Quality and timely reporting of KPI and customer response
  • Complaint and/or AE intake reporting compliance
  • No critical findings in audits or inspections
  • Customer feedback and satisfaction

    • Associate is authorized:

  • To manage any follow up with the complainant, and to update into the GPCMS
  • To prepare the final response according to the Quality Summary (prepared by Alcon's global device vigilance colleague) and forward the notification to the Healthcare Professional
  • To arrange the return of any product compliant sample to the manufacturer for investigation
  • To manage and work within Alcon representative into any customer and/or product responses, and feedback within agreeable timeline
  • To conduct reconciliation with Alcon representative and report out within agreeable timeline
  • Education :
  • Tertiary qualification in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline
  • Languages:
  • Fluent in Korean and English (spoken and written)
  • Fluent in Mandarin and Cantonese (spoken and written)
  • Key Competencies/Behaviours:
  • Technically Competent.
  • Results Driven
  • Customer / Quality Focus
  • Empowerment / Accountability
  • Mutual Respect / Trust / Loyalty
  • Experience:
  • 1- 2 years of experience in pharmaceutical and medical device industries
  • Proven ability in implementing quality and documentation systems.
  • Record of accomplishment of tracking complaints
  • Effective communicator
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