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QA Specialist, Biopharma (Pharmacist, 신입지원가능)

Your Role:

The purpose of the Quality Specialist role is to support the Quality Manager in the performance of Quality and Compliance tasks for South Korea with regards to GMP and GDP requirements (including Medical Device guidelines) as well as . 

 

Support the Quality Manager with the implementation of the defined Global Healthcare Operations strategy and ensure the implementation and monitoring of the Quality Management System and their continuous improvement. 

 

Tasks will include the management of product release, documentation, metrics / trend reports for both complaints and deviations.  In addition, this role will provide assistance to the field force with regard to complaint management.

 

Another key area of this role is assistance to the registered pharmacist as a deputy with the following responsibilities.

  • Product Release: As a Deputy of the registered pharmacist, manage the release procedure of drug products including review of shipping documents, product certificates(CoA or CoC) and temperature loggers, in bound inspection report and batch records
  • Particpate in the Right First Time objective as part of product release activities and work with stakeholders to share the information and improve local processes as necessary
  • Actively participate in the Company Performance Management Process and Personal Development plan
  • Assist the customer complaints Process including the investigation process, maintenance of  appropriate documentation, recording and investigation of customer complaints via the complaint database TrackWise; return of complaint samples to manufacturing sites for investigation purposes and provision of information to complainants as required (complaint responses)
  • To recognize a reportable adverse event(AE) and/or safety information which may be related to our products and ensure that the necessary information is forwarded to the Local Patient Safety Responsible Person (LPSR) within 24 hours
  • Assist with the creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via Mango.
  • Assist with preparing training presentations as needed
  • Assist with audit and inspection management / preparation carried out by the Health Authorities and corporate internal audits.
  • Assist with Risk Management activities
  • Work within company Standard Operating Procedures, industry guidelines and apply our Values and Code of Conduct in daily duties and activities.
  • Perform other functions and duties that may be assigned by the Head of Quality.
  • Other tasks assigned by your superior.

 

 

Who You Are:

  • Certificate of Pharmacist (Korea)
  • Less than 1 year of work experience in Pharmaceutical industry preferable but not mandatory
  • Business Proficient in English
  • Proactive and highly motivated individual with career aspirations in QA field
  • Teamwork and interpersonal skills

 

 

보훈대상자 취업보호대상자는 관련법에 의거하여 우대합니다.

지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 있습니다

•(The company reserves the right to withdraw the offer, it if discovers subsequently that a candidate has given false information in application or has provided false or fraudulent documentation in support of his/her application. The offer is conditional upon satisfactory results of reference checks.)

Job Requisition ID:  206551
Location:  Seoul - all
Career Level:  B - Recent University Graduate(<1 year of experien
Working time model:  full-time

US Disclosure
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.

North America Disclosure
The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.


Job Segment: Pharmacy, Medical, Quality Manager, Pharmaceutical, QA, Healthcare, Quality, Science

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