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QA Specialist, Pharmacist

Your Role:

The purpose of the role is to serve as Registered pharmacist for Merck Korea Ltd and to assure that quality operations are compliant with GIP, GMP and GDP requirements . 

 

Support Head of Quality 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, deviations/OOS and CAPA.  In addition, this role will provide primary contact point to the authorities for consultation of quality and compliance issues.

  • Product Release: As a 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
  • Oversight of GMP/GDP operations to assure compliance with regulatory requirements of GIP, GMP and GDP.
  • 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 Merck Performance Management Process and Personal Development plan
  • Manage deviation including the investigation process, maintenance of  appropriate documentation, recording of investigation and CAPA using TrackWise
  • To recognize a reportable adverse event(AE) and/or safety information which may be related to a Merck products and ensure that the necessary information is forwarded to the Local Patient Safety Responsible Person (LPSR) within 24 hours
  • Participate in the creation and maintenance (periodic review) of Quality Standard Operating Procedures and Work Instructions and ensuring procedures are available via Mango. 
  • Participate in preparing training presentations as needed
  • Participate in audit and inspection management / preparation carried out by the Health Authorities and corporate intrernal audits.
  • Participate in Risk Management activities
  • Work within company Standard Operating Procedures, industry guidelines and apply Merck Values and Code of Conduct in daily duties and activities.
  • Perform other functions and duties that may be assigned by the Head of Quality

 

 

Who You Are:

  • Certificate of Pharmacist (Korea)
  • Over 2 year of work experience in Pharmaceutical industry mandatory
  • Business Proficient in English
  • Proactive and highly motivated individual with career aspirations in QA field
  • Teamwork and interpersonal skills

 

 

•보훈대상자 및 취업보호대상자는 관련법에 의거하여 우대합니다.

•지원서의 기재사항이 사실과 다른 것으로 확인되거나 Reference from previous employer 상에 채용상의 결격사유가 확인될 경우 합격 또는 채용이 취소될 수 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:  210664
Location:  Seoul - all
Career Level:  C - Professional (1-3 years)
Working time model:  full-time

Careers during Covid-19
Thank you for visiting our careers website, we are always looking for curious minds to join our teams. We understand how much the world is being impacted by the Covid-19 crisis and we want to assure you that your safety is very important to us. To ensure that everyone’s health is protected, instead of a standard face-to-face interview, it is likely that you will be offered alternative digital interview options.

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.

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