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MG-QC/Regulatory Officer (保健食品)

發表於: 31 Mar 2018

工作內容:

Vision and strategy

-Understand and commit to corporate and department vision and values.

-Understand and commit to department objectives.

Quality

-Inspect incoming finished goods against product specification.

-Review certificate of analysis against product specification.

-Review / Audit Batch records form manufacturers.

-Control release status of products in Enterprise One business system.

-Advise manufacturers of Approval to release. (Release for Supply function)

-Data entry into Enterprise One business system.

-Maintain local Quality documentation and retention samples.

- Assess Out of Specification results and provide guidance.

-Liaise with Quality Manager and other Quality personnel on problems relating to products, documentation.

Regulatory Affairs

-Review product specification to ensure compliance with local regulation.

- Review artwork for compliance to local regulation.

-Generate accurate English translation of artwork and relevant dossiers for filing in Head Office.

-Submit sample for testing as required.

-Co-ordinate registration submission to local regulatory authority.  

-Liase with Regulatory personel in Head Office of any regulatory issues.

-Provide regulatory advice to support regulatory compliance.

Occupational health and safety

-Work safely and not place at risk the health and safety of other employees, visitors or the public

-Comply with all safety procedures, rules & instructions

-Use all safety and personal protective equipment as directed

-Maintain the work area and amenities in a clean and tidy condition

 

Requirement:

- Relationship Management – Contractors and suppliers

-Software Applications - MS Word, Excel, PowerPoint and Outlook, Enterprise One, Access, SharePoint

-Writing Skills – Technical / SOP writing

-Tertiary qualifications in a Science related field

-Understanding of GMP and it’s application

-Understanding of technical issues in manufacturing.

- Experience in pharmaceutical, food or related industry

行業: 法律
其他
職業: 醫療保健/生命科學/生物/製藥產業
其他
工作地: 台北市
僱傭類型: 全職
工作經驗: 5
薪資範圍: 面議

For enquiries, you can contact Meg Yen for a confidential discussion.

Email: meg@recruitexpress.com.tw

Contact: 0287806822

**All information will be treated with the strictest confidence. We regret that only short-listed applicants will be notified.