潍坊招聘

Responsibilities
Perform audits
?prepare supplier audits and collect information from internal and external sources
?align audit focus and audit depth with BI OPUs in the delegation system
?perform delegated supplier audits on behalf of all OPUs or Corporate Division SQE for APIs, excipients, packaging material, starting materials, intermediates according to a pre-defined plan and assess the quality systems and the GMP compliance level of suppliers
?identify risks and assign risk categories for the deficiencies observed
?communicate risks resulting from suppliers
?document audit results in audit reports

Follow-up audits
?review and assess adequacy of corrective/preventive action plans of suppliers
?monitor the completion of corrective/preventive action plans
?trend audit findings and identify areas for improvement
?identify and share best practice

Support suppliers with cGMP, GDP and quality systems know how
?promote compliance with cGMP, GDP by performing training for suppliers

Support establishing and continuously developing the supplier qualification system in China
?establish and implement standard operating procedures
?conduct risk assessments and perform gap analysis
?identify risk mitigation strategies
?perform market surveillance and provide critical information:

Report suspicious incidents and shortages to the Global network,
reporting, trending and dissemination of information to the Global network
?develop proactive measures to prevent negative consequences for company

Support inspections/audits in China manufacturing sites and CoC
?support the manufacturing site or the CoC to prepare foreign regulatory inspections

Knowledge and skill requirements
Knowledge
?Bachelor's or Master' degree in science
?Minimum 5 years of experience in a GMP regulated environment
?Broad experience in auditing
?Expert knowledge of international regulations regarding Good Manufacturing Practice (GMP) and Good Distribution Practice for Active Pharmaceutical Ingredients (APIs) and pharmaceutical products (GDP)
?In-depth knowledge of Quality Systems and related norms (e.g. ICH 8/9/10, ISO 9000 series)
?Fluent in written and spoken English as well as Chinese
3.2. Skills
? Excellent communication skills, persistence, commitment and mobility
? Dispute resolution and decision making skills
? Inter-cultural competence
? Skillful in using office application software (

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.

Our Values: Faith Efficiency Professionalism

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

@优锐人才 weibo.com/acutalent