潍坊招聘

Basic Purpose of the Position*
Is responsible for establish, maintain and continuously improve the performance and reliability of the integrated CAPA system, batch release, PQR, Supplier Management, Internal GMP Audit, Training, GMP documentation management etc. to ensure the site is in line with GMP compliance.
负责建立, 维护和持续改进整合的ＣＡＰＡ系统，产品放行，年度产品回顾，供应商管理，GMP内部审计，培训， GMP文件管理等的可靠性以确保工厂符合GMP。

100% batch release full complies with GMP and corporate requirement.
Integrated to support to identify the potential risk and improve the quality.
Provide timely QA support for deviations root cause investigation, CAPA plan setting and follow up.
Maintain and optimize the APR system to reflect the quality trending and proactive taking action to keep the quality system align with corporate standard
Maintain and optimize supplier management to align with regulation requirement and the strategy goal and improve the transparancy
Maintain and optimize internal and external audit to continues improve the effect and efficiency of quality management
Manage, evaluating and optimize the training system to ensure the training is implemented efficiently, cost allowable and effectively.
Maintain and optimize the GMP documentation system to ensure all documents are managed align with SFDA and guideline requirements under GMP condition with simplify, efficient and allowable cost.

Requirements
Along with the peer group responsible for the Implementation of the strategy of the Quality Assurance Department and to optimize efficiency with regard to cost and quality and operational targets

Effective and efficient management of available resources to meet the operational requirements of GMP, corporate guidelines, policies, procedures and industry standards to ensure ongoing compliance of quality.

Establish team objectives, targets and standards within the context of the overall organizational strategy in order to meet operational and corporate objectives

This role should have ability to cross management within QA function.
?This person must have a clear understanding to the Chinese environment both from a personnel perspective, the culture and the regulatory bodies (SFDA) and the requirements that they have.
?Must be able to be customer focused and have clear metric deliverables available to them.
?A mindset of continuous improvement through China LEAN is a pre-requisite

.Batchelor Degree Above,Pharmacy or relevant
?Experience of working in a pharmaceutical quality assurance environment
?Minimum of 3 years experience of QA, of which 1 should be at a specialist level
?Understanding of the regulatory requirements of the Pharmaceutical Industry including a good working knowledge of GMP standards, validation, supply chain processes
?Good audit skill
?Good problem solving skill, communication skill
?Strong Leadership

Acutalent HR Consulting Co., Ltd. is an executive search firm focusing on searching for middle to senior management positions for our European, American, and Japanese multinational company clients. Meanwhile, we provide career development plans to mid and above level customers in Acutalent’s talent pool.

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Core Competency:
- Comprehension of industries we served and positions we hunted
- Accessibility to assorted talent pool
- Recognition and Acceptance by talents
- Capability to match company and talent needs

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