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水平: Entry level
工作类型: Full-time
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工作内容
In coordination with the relevant management, the QP is responsible for the implementation and maintenance of an effective Quality Management System.The QP:
- Ensures that operations related to raw materials, imported or manufactured bulk pharmaceutical products, and packaged finished products comply with national and/or international regulations and guidelines (cGMP).
- Ensures that products conform to their marketing authorization dossiers.
- Makes decisions regarding batch release, rejection, or rework of products.
- Proactively supports operations in identifying, developing, and implementing quality and operational excellence improvements in response to business needs, technical changes, and regulatory requirements.
- Release and certification of the above-mentioned product batches, including the management of legal samples.
- Management of quality deviations, investigations, CAPAs, market/client complaints, recalls, temporary and permanent change controls, and authorization of retests and reprocessing/rework.
- Review and approval of Product Quality Reviews (PQR) and Line Quality Reviews.
- Drafting, reviewing, and approving procedures related to the scope of activity.
- QA monitoring and support for projects defined by QA management, specifically those related to release activities.
- Conducting internal audits and participating in customer audits and regulatory inspections within the scope of responsibility
- Degree in Industrial Pharmacy with a valid Qualified Person (QP) registration number.
- Experience in a GMP pharmaceutical environment in a similar role and/or in Quality Assurance, Production, or Quality Control.
- Strong knowledge of international GMP regulations relevant to the activities.
- Strong sense of confidentiality and integrity.
- Excellent team spirit and interpersonal skills, including effective written and verbal communication.
- Ability to communicate effectively and interact easily with production teams on the shop floor and QC/QA laboratory staff.
- Capacity to work under pressure.
- Strong problem-solving skills and ability to propose constructive and innovative solutions.
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最后期限: 05-01-2026
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