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[제약] QA Specialist (1년 계약직)
A career at our company is an ongoing journey of discovery: our 60,300 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
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.)
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences.
We celebrate all dimensions of diversity. We believe that it drives excellence, innovation, and human progress. We care about our customers, patients, and our rich mix of people. This diversity strengthens our ability to lead in science and technology.
We are committed to creating access and opportunities for all and empower you to fulfil your ambitions. Our diverse businesses offer various career moves to seek new horizons.
Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to bring their curiosity to life!
Curious? Chat with one of our curious minds on our interactive Q&A platform and catch a glimpse of our people, values, and culture. You can also apply and find more information at https://jobs.vibrantm.com
If you would like to know more about what diversity, equity, and inclusion means to us, please visit https://www.merckgroup.com/en/company/press-positions.html