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[담당업무] Quality Assurance:
Act as the local quality assurance/quality system representative for the affiliate
Establish and manage the affiliate Quality Management System and Quality Assurance activities to ensure compliance with all regulatory and GxP requirements;
Host audits/inspections on behalf of GxP functions within the affiliate
Maintain quality assurance activities for GxP programs/activities
To supervise the commercial batch release procedures with the local partners and concerned Authorities.
Focuses on proactive crisis prevention and supports crisis and CAPA follow-up when needed
Drives remediation plan when a product quality or GxP process issue is identified
Maintain and ensure local Product Complaints and recalls management
To ensure Technical Direction of the distribution activity, acting as local Responsible Person for local Authorities and main contact for distribution issues / GDP inspections;
To control, in conjunction with local distributor(s), the reception, warehousing and distribution of the products;
To ensure that distributors comply with Good Distribution Practices (in particular cold chain and transportation).
Integrate global/corporate and Affiliate quality needs and priorities, including representing the Affiliate at the Global Quality Forum
Encourage best practices and a high performing “quality beyond compliance” culture, both from
procedural and patient/customer centricity perspectives
Contribute strongly to building quality and compliance through governance and education
Proactively assess regulatory changes and where necessary, escalate with technical expertise, assessment and solution proposals;
Ensures comprehensive training program covering all GxP activities
Ensure the affiliate’s self-inspection, GxP audit readiness; business continuity, change control, Deviations and CAPA management systems and activities are in place and implemented to cover GxP processes,
Conduct and/or host risk assessments, self-inspections, regulatory inspections, audits, mock-recalls
and should the situation arise, to act as Affiliate Product Recall Lead;
Support, Oversee and manage any local analytical product release activities (Analytical transfers; Protocol and Report reviews; Facilitate troubleshooting; support any OOS; Product release)
Quality interface for local Distribution partners.
Manage repackaging activities (Repackaging operation, Material management, Batch documentation) ensuring regulatory and QA compliance, timely QA batch release of repacked orders before distribution.
Provide artwork management process consultation to relevant business functions
Job Requirements
Education / Certifications:
Ideal: Degree in Medicine or Pharmacy
Minimum: Degree in Scientific discipline (Pharmacy, Chemistry, or Biological Sciences)
Experience:
At least 5 to 7 years experience in a similar position in a multinational pharmaceutical company
Strong quality orientation
Ability to work with high workload and time pressure
Strong negotiation skills
Computer literacy skills
Strong organisational abilities
Ability to balance between detail orientation and overview with a good business acumen
Broad pharmaceutical business knowledge
Start-up experience desirable
Proven experience and leadership within Quality operations of multi-national biopharmaceutical settings;
Extensive understanding of GxP, Quality Systems and Pharmaceutical responsibilities, with experience as Local/Site QA and EHS Lead or Representative;
Languages:
Fluent in Korean and English.
[근무부서 및 직급/직책]
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