General

Job Title:                Compliance Manager
Location:                ChangPing, Beijing China

1. Assurance that the Product Quality confirms to specifications and that Products’ production activity compliance with Quality Policy and GMP requirement
2. Ensure Products conforming to specifications, to production standards and to all Good Manufacturing Practices as stipulated in the SOPs
3. Ensure that Technical Operation Personnel is trained and educated to obtain and possess the skills required to manufacture high quality Pharmaceutical Products
4. Monitor PO routine quality relevant activities complied with SOP requirement and are documented in line with GMP requirement
5. Provide effective assistance to each relative Section from GMP compliance point of view. Include local regulatory compliance
6. Access and availability of know-how in respect to “state of the art” GMP know-how and future trends in the field of GMP, PIC, Validation etc
7. Organize and manage compliance sub-section performance towards Global standard

Back-Ground Requirements

  Education: University Graduate in Pharmacy or Chemistry
Languages: Fluent in spoken, written, listen and read English and Chinese
 Experiences:

1. 4-6 years experience in the quality assurance field in Pharmaceutical industry, JV experience has priority
2. Supervisory functions in quality assurance
3. Practical experiences in compliance and QC

Capabilities Required

  Intellectual skills

1. Organizational and managerial skills
2. Analytical and creative thinking
3. Comprehensive analytical and solve problem ability
4. Persistent, organized and systematic in her/his work
5. Practical and common sense
6. Good general understanding for QC, Production and Engineering aspects
7. Innovative, speed and precise working style

  Social skills

1. Skills for management of people
2. Leadership qualities
3. Team spirit
4. Skills to transfer know-how to her/his subordinates
5. Skills to train and motivate subordinates effectively

Emotional Factors

1. Open minded and mature character
2. Strong personality, with good control of emotions
3. Sense for urgency to reach specific goals
4. Withstand stress situations
5. Flexible personality, adaptable to changing situations
6. Hard working and enthusiastic type (not only professional but  also towards the country and its people)
7. Patient, affinity
8. High Communication skill

 

Motivation Required

  Motivation Profile

1. Dynamic, capable and determined person
2. Self-motivator and stimulator
3. Setting demanding goals and pass for himself
4. Committed to excellence
5. Job satisfaction

  Career Expectations

1. Take over the Compliance responsibility in Quality Assurance Department
2. Eventually, successor to Head of Quality Assurance

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