The purpose of the Quality Specialist role is to support global digitalization project with global TFT and support the Quality manager in the performance of Quality and Compliance tasks for South Korea with regards to GIP and GDP requirements (including Medical Device guidelines), as well as, support the Quality team 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.
Key area of this role is assistance to Quality colleagues as an associate with the following responsibilities:
Support global digitalization project: attend regular meeting to share any idea to improve process digitalization.
Product Release: Support 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
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:
Bachelor’s degree in biology, chemistry, or related field is preferred
Fresh graduate or less than 2 years of work experience in Pharmaceutical industry preferable but not mandatory
Visual basic, coding, software, or related programming experience/understanding is highly preferred
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.)