QA Complaint Handling Associate

1 week ago

Klang, Selangor, Malaysia Alcon Full time
At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you'll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon.

Job Overview


Responsible for day-to-day case management of quality technical and adverse event (AE) complaint records, including intake, acknowledgement, follow up, triage, system entry and final response, involving Alcon devices, pharmaceutical products, over-the-counter products.

Complaint handling accountabilities reflect activities required to comply with local and international regulations, guidelines and applicable directives.


Responsible for day-to-day case management of unsolicited medical inquiries from eye care professionals (ECP), consumers and internal partners, including intake, acknowledgement, follow up, documentation, development and provisions of responses involving Alcon devices, pharmaceutical products, over-the-counter products.

Triage requests appropriately and document interactions directly into the approved department medical information repository/ database.

Key Responsibilities:

  • Receive initial complaint from any source (e.g. ECP, patients, internal/ external Alcon representatives) and assure all information/ data is accurately captured at point of contact
  • Maintain an understanding of information/ data required to be collected for technical and AE complaints to assure compliance with regulations and directives
  • Manage technical and AE complaint records for assigned area(s) using designated safety system(s)
  • Review potential complaint data received via safety system(s) and other methods, as required.
  • Is cognizant of, and works efficiently within applicable time zones
  • Performs all necessary reconciliation activities including for all customer oriented programs in accordance with procedures
  • Triage/ address calls from all sources for quality technical complaint, AE, requests for refund/ replacement product and credit
  • Adheres to required metrics for all complaint handling responsibilities
  • Arrange for replacement, product return and shipping of samples to QA sites for analysis
  • Closes files according to established guidelines to meet required timelines
  • Maintain a working knowledge of:
  • Company policies and procedures, departmental processes, and associated work instructions
  • Evolving local and international regulations, guidelines and applicable directives
  • Alcon products for assigned therapeutics area(s) and corresponding documentation (Product Inserts, Direction for Use (DFU), Manuals, Promotional Materials)
  • Eye anatomy, common diseases, ophthalmic procedures, terminology
  • Complaint management system, safety database and reporting tools
  • Informs management of potential safety issues, emerging trends and/or concerns
  • Ensure that a business continuity plan is in place which is aimed at guarantee the uninterrupted availability of key vigilance processes and activities, or mitigate the impact of an unwanted event by means of measures and procedures enabling efficient and effective business resumption and/ or recovery, exists and has been test-ed accordingly
Key Performance Indicators (KPI)- Quality and timely reporting of KPI and safety reports/updates- Complaint and/or AE intake reporting compliance- No critical findings in audits or inspections- Customer feedback and satisfaction

WHAT YOU'LL BRING TO ALCON:

  • Minimum: graduation in science.
  • Ophthalmology/ Eye care experience desirable
  • Desirable: university degree in optometry/ pharmacy/ ophthalmology/ medicine/ pharmacology/ biomedical science/ biomedical engineering/ chemistry/ biology/ nursing or other healthcare discipline.
  • Fluent in both written and spoken English & Korean 1 year of experience in customer service, complaints handling, quality management system or similar
  • Experience working within multinational pharma companies or medical device company desirable
  • Comprehensive understanding of national and international regulations for medical device vigilance and pharmacovigilance, medical terminology

HOW YOU CAN THRIVE AT ALCON:

  • Opportunity to work with a leading global medical device company.
  • Collaborate with a diverse and talented team in a supportive work environment.
  • Competitive compensation package and comprehensive benefits.
  • Continuous learning and development opportunities.
Alcon Careers

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