Looking
for a chance to make a real difference in the oncology space? Taiho Oncology is
on a mission: to improve the lives of cancer patients, their families, and
caregivers. Our “People first” approach means we also value our employees, who
work relentlessly to help us execute our mission. Taiho’s success is founded on
ensuring we always act with accountability, collaboration, and trust. By
following these guiding principles, we earn and maintain the confidence of our
patients, our partners, and each other. Together, we’re working to discover and
develop innovative cancer treatments that address unmet patient needs and apply
the science behind them in novel ways. As the field of cancer treatment
evolves, we evolve with it. Advanced technology, dedicated investigators, and
incomparable facilities: these vast resources empower us to redefine the way
the world treats cancer. It’s our work, our passion, and our legacy. If the
prospect of being part of this sounds exciting, we invite you to join us.
 

Position Summary:     

Due to the highly regulated and
confidential nature of Quality Assurance, this position requires a positive and
experienced professional with a focus on high quality detailed work,
initiative, sound judgment, and work ownership. The incumbent is responsible
for initial receipt and log-in of product complaints, assessment and
maintenance of other QA documents, as assigned. The incumbent must have a demonstrated
proficiency in Microsoft office, work in collaboration with others and provide
independent thought to improve processes for projects and department operations
with the ability to communicate effectively at all levels of the company.
 

Responsibilities and Duties: 

• Receive and enter complaint information into the
  complaint database for evaluation by QA GMP.


• Evaluate the initial complaint and determine the
  need for investigations


• Identify product complaints that may be linked to
  an adverse event


• Sends out requests for complaint
  follow-up based on the complaint evaluation


• Maintain and complete PQC monthly
  notebooks


• Track complaint progress to ensure
  complaints are closed on time. Escalates when timelines cannot be complete


• Interact with drug manufacturer and
  packager during complaint investigations


• Perform PQC case reconciliation with all involved
  vendors


• Test TrackWise workflow and participate in review
  of procedures as they are adapted to TrackWise


• Participate in the testing of the
  TrackWise system modules


• Assist QA with the conduct of internal
  audits.


• Assist quality personnel in activities to
  accomplish company goals.


• Assist QA management in preparing process metrics
  and progress reports.


• Propose process improvements related to the QA
  function.


• Receives GSOPs from TPC and upload them
  into Master Control (MC)


• Update Table of Contents for GSOPs


• Maintain library books of procedures up-to-date


• Upload, and format, company procedures in MC


• Launch SOPs, Guidances and WI in MC


• Set effective date and Launching Training
  for all company employees


• Assist in the execution of UAT, as needed


• Perform other related duties as assigned.

Experience: 

• Considerable experience in a
  pharmaceutical industry working in a regulatory or quality assurance
  department.


• Solid knowledge and experience on QA/QC
  processes.-


• Solid knowledge in handling product
  complaints


• Experience with tracking systems for
  product complaint, change control, and investigations.


• Experience with Master Control and/or TrackWise
  system is a plus 
  

Educational Requirements:   

• High school degree is mandatory, college
  degree preferred with at least three years related pharmaceutical/technical quality
  assurance or regulatory documentation experience, or equivalent experience.