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STA Pacific Limited

QA Specialist, Global Healthcare Manufacturer

STA Pacific Limited
Salary negotiable
Posted on 24 Jan 2020

QA Specialist, Global Healthcare Manufacturer

STA Pacific Limited

Job Highlights

  • a renowned multinational healthcare manufacturer
  • quality assurance and Pharmacovigilence experience
  • pharmaceutical or medical device industry

Job Description

Our client is a renowned multinational healthcare manufacturer with well-established operations around the globe.  They are looking for QA Specialist talents to join their company.

Major Roles and Responsibilities: 

Quality Assurance 

  • Perform and handle QA activities in office and technical support field including: product release, product return and repackaging related activities to ensure compliance of GMP
  • Handle customer complaints effectively, ensure timely escalation of quality incident and maintain customer satisfaction
  • Prepare complaint investigation report
  • Monitor & review complaint metrics against targets provide oversight for improvement
  • Coordinate cross-functional team and 3rd party’s warehouse to prepare internal audit and DH inspection
  • Manage supplier qualification process. Coordinate with cross-functional team and regional Supplier Quality
  • Support to manage 3rd party’s and distributor’s warehouse performance
  • Ensure implementation of Quality Management System at local level includes document control
  • Support for CAPA and change control
  • Handle ad hoc projects

Pharmacovigilence 

  • Maintain an efficient pharmacovigilance system in compliance with the local authority’s regulation and Regional policies and SOP
  • Provide PV awareness training to all staff and vendor
  • Handling Adverse Event reporting and submission according to regulatory requirements
  • Manage day-to-day AE receipt and reporting. Track AE cases and perform case follow-ups as needed
  • Conduct initial quality review and assessment of local individual cases
  • Perform regular reconciliation activities as required by company procedures and local regulations
  • Perform local literature surveillance; detect and report AEs from local literature
  • Collaborate with regulatory affair, quality assurance appropriate departments/vendor on the safety relevant requirement.

 Requirement:

  • Bachelor degree or above in related scientific discipline
  • Minimum 2 years of relevant experience in pharmaceutical or medical device industry
  • Detail-minded and passionate team player
  • Fluency in spoken and written English, Cantonese and Mandarin

Interested parties please send your CV by clicking "Apply Now"or email to [email protected] stapacific.com.  All personal information will be used strictly for recruitment purpose.  Please assume your application has not been successful if you have not heard from us in two weeks' time.

Additional Information

Career Level
Middle
Qualification
Degree
Years of Experience
1 year
Employment Type
Full Time, Permanent
Job Functions

Company Overview

Helping You Achieve Your Career Goals.

STA is a premier executive search and selection consultancy, specializing in talent acquisition for senior, middle and specialist level positions across Asia Pacific in Consumer, Life Sciences & Medical, Hospitality, IT&T as well as other technology sectors.

We pride ourselves with a team of professionally qualified consultants and researchers that have fulfilled positions at various levels for global multinationals.  We are always ready to share with you expert knowledge in your industry, market outlook and client requirements to help you develop your career path and achieve your goals.

Rest assured that we respect your privacy and keep all information sent to us confidential.  We always ask your permission before sending a resume to a client.

Additional Company Information

Benefits & Others
Dental insurance, Five-day work week, Medical insurance, Performance bonus