職位描述
Four Main Responsibilities:
60%-Manage label control activities to meet China Regulation and Abbott Nutrition Division Requirements.
10%-Give the update China Regulation and AN Policy to the plant.
30%-Manage Label change control, track and document all the labels with China Affiliate Marketing Team, Medical Team and Regulatory Team.
Major Responsibilities/Activities:
Establish and maintain site local procedures consistent with Abbott Nutrition QA Policy and China Regulations.
Initiate required plant labeling documents and provide necessary documents to create their label.
Manage label initiation, review & approval process and time tracking by working with China Medical, Regulatory and Marketing team.
Complete peer review tasks to ensure completeness and correctness per functional role responsibilities as defined in AN Label Cha nge Control Process.
Ensure change control documentation is accurate and complete with appropriate approval signatures/date.
Review product claims and assure label claims have been verified through product testing,? and ensure label content is accurate.
Verify that the assigned label specific bar code matches the bar code of the final label artwork.
Ensure all reviews and approvals for label development process are completed, and ensure all approvals have been received.
Ensure adequate reasons and justifications are provided to justify deviating from defined Workflow Approval Types.
Use Label Proofing System to ensure supplier .pdf matches the Approved .pdf .Maintain label history files per appropriate Abbott Nutrition requirements.
REQUIREMENTS:
Industry experiences: Involved in Label control activities in food/pharmaceutical manufacturingKnowledge of Quality systems would be preferred. Working exposure and understanding of manufacturing process. Good practical knowledge of GMP in food/pharmaceutical manufacturing.
Position experiences: 2 to 3 years of quality relevant experience or equivalent combination of education and work experienceProject tracking and management skills or experience in project management is essential. Team player with imitative, drive, good communication skillsProven problem-solving capability, customer focus and commitment to continuousCan work under pressure while staying positive. Good working attitude.?Language Skills：Fluent usage of English and Mandarin (both spoken and written).? English translation to Chinese and Chinese to English need to be good. Require English qualification certificate as either one of these: CET4; CET6; TEM4; TEM8.?Computer Skills: Proficient in basic microsoft office
