求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Quality Assurance Manager

  • 全職

To act as Responsible Person for IAC in accordance with applicable regulations (e.g. GxP, ISO, HACCP etc.) for Mundipharma Products

Including but not limited to:

Licensing
o Ensuring appropriate certification (e.g. GMP, GDP, GDPMDS, GDPMD, GQP, ISO, HACCP) is attained and sustained as required.
o Provide expert advice on licensing requirements for IAC.
o Ensure that correct licenses are held at all times, if necessary.
o Maintain and control the master list of products for IAC.
o Liaise with regulatory to ensure that the information in the product list is kept current and that all product information and labelling are in compliance with local and where applicable international regulations, codes and standards.

Quality Management
o Information to senior management if any aspect of the business or plant’s operations is not in accordance with GxP guidelines.
o Ensuring all aspects of product handling and distribution are performed in accordance with regulatory requirements, local quality standards and Mundipharma regulations.
o Implementation of quality and GxP regulations as well as any other relevant standards, maintaining awareness of trends in industry and implementing necessary changes.
o Ensuring external inspections, complaints, recall, deviations, CAPA, incidents of counterfeiting and tampering, supplier performance and other relevant quality performance measures are raised, investigated, reported, trended and communicated to those required and management.

Personnel
o Ensures the initial and continuous training programme is implemented and maintained. Plans and records should reflect training activities

Documentation
o Ensuring the management of authorized activities and the accuracy and quality of records. Records should be available as evidence and traceability of activities performed with respect to the quality, strength, purity, safety, identity and traceability of the product and integrity of the pack.
o Ensures that documentation and records are managed throughout their life cycle.
o Ensures an effective CAPA system for recording of all actions for correction, prevention and improvement, with monitoring for closure in a timely manner.

Operations
o Ensure the compliance of repacking, relabeling, storage, distribution and transport are in accordance with GDP or applicable regulations, licensing and Mundipharma standards and responsibilities defined by technical agreement and approved prior to use.
o Ensures changes related to product, third parties, key business activities, artwork, etc are raised, evaluated and implemented via a change control system.
o Assisting in audit, approval, supervision and co-ordination of third party activities.

Complaints, Returns, Suspected Falsified Products and Product Recalls
o Establish and maintain receipt, investigation, tracking, trending and communication of complaints. This includes notification to authority as per the current regulatory requirements. Ensure escalation and notification in line with regulatory and Mundipharma standards and timelines.
o Deciding on the final disposition of returned, rejected, recalled or falsified/counterfeit products
o Approving of any returns to saleable stock

Self-inspections
o Ensuring that internal audit programme is established, maintained and communicated. Actions identified should be tracked as CAPA. Schedule should reflect requirement for audit on at least an annual basis.

Qualifications and Experience:
Degree in Pharmacy, Chemistry or related discipline. Registered Pharmacist is preferred.
A minimum of 5 years’ experience in GxP (e.g. Good Distribution Practice) for at least one of the preferred categories or equivalent.
A minimum 3 years being responsible for the operational management of a GDP/GMP Quality Management System including decision making for product release or equivalent.
Trained internal auditor for GMP/GDP
Fluent in Spoken and Written English

工作條件

  • 接受身份: 上班族、中壯齡(45~54歲)
  • 工作經歷: 不拘
  • 學歷要求: 大學以上
  • 語文條件: 不拘
  • 其它條件: 未填寫
更新日期:2021-09-09

應徵方式

  • 職務聯絡人: BlancheChan
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年0%
5~10年0%
10年以上50%
學歷分佈
碩士及以上0%
大學100%
專科0%
高中0%
高中以下0%
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