Marketing Company Operations Quality Specialist

[Job Description]

Management of local testing to support the market activities

• Manage a process of Analytical Technology Transfer from the donor lab to the
• receiving lab in order to secure the implementation timeline and compliance to local regulation.
• Manage the supply of reference standards & testing samples to support local testing
• Manage the deviation of the local test such as OOT (out of trend) and OOS (out of specification)
• Management, documentation and inspection of the third parties from various stakeholders.
• Support New Drug/ Biologics Application or Life Cycle Management in terms of quality (Chemical, Manufacturing and Controls)

Support Product registration

• Prepare Product specification and Analytical method section of new products in Korea by sourcing necessary documents from HQ’s worldwide regulatory function

Management of the quality system in AstraZeneca Korea in line with registered
product information.

• Ensure that all the quality standards & local regulations are implemented in all the relevant operating guidelines & SOPs
• Prepare for regular inspection of MFDS
• Review local SOPs concerned and update

Management of Product Quality Complaint

• Handling of the complaints for imported products and toll manufacturing products
• Upload and report information on any complaint of the imported product regarding technical/pharmaceutical quality system or local manufacturer
• Sending samples to the concerned Production site
• Investigate and discuss with sales & MKT to coordinate correctly
• Confirming feedback of the complaint from Production site
• Providing the customer with an adequate reply based on the investigation made by the Production Unit.

[Skills]

• Suggested skills based on Job Details
• Project management

[Qualifications]

• Education: Bachelor's degree or higher
• Language: Good command of spoken and written English
• Certifications: Pharmacist preferred
• Work Experience: More than 5 years of experience in the quality department in pharmaceutical company or R&D lab.
• Competencies: Project management, Risk management, Proactive communication with internal and external stakeholders.

※ 채용 절차법에 따른 고지 사항

1. 전자우편으로제출한서류는채용절차법에따라, 일체반환의무가없습니다.

2. 보훈대상자 및 취업보호대상자는관련법에의거하여우대합니다.

3. 해외여행결격사유가없어야합니다.

4. 본 채용은수시진행으로, 우수인력채용 시 마감될 수 있습니다.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.