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.
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What You Will Do
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 an associate with the following responsibilities:
- Product Release: Support the release procedure of drug products including review of shipping documents, product certificates(CoA or CoC) and temperature loggers, inbound 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.
Required Skills and Abilities
- Bachelor’s degree or above 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.
- Business Proficient in English.
- Proactive and highly motivated individual with career aspirations in QA field.
- Teamwork and interpersonal skills.
- Job type:Graduate Jobs
Medical and Biomedical Science, Pharmacy and...
Seoul (South Korea)
- Closing Date:8th Feb 2022, 6:00 pm