天津招聘

职位描述：
The candidate should be experienced with quality assurance skills in both plant and regional level. GMP familiarity is a must.

Please send your updated Word English & Chinese CVs to jwu[at]bundconsulting[dot]com.

Responsibilities
? Overseeing the implementation of internal and external audits and developing corrective action plans. Coordinates the G.M.P. self-audits at each facility to ensure adherence to Melaleuca Quality Assurance S.O.P.'s and other relevant regional regulations. Also oversees the inspection and G.M.P. compliance auditing of current and prospective third-party manufacturers.
? Responsible for compliance to Good Manufacturing Practices and other applicable regulations (example: dietary supplements) within China, Korea, Japan, Taiwan, Hong Kong and the Association of Southeast Asian Nations (ASEAN).
? Overseeing the implementation of a consumer complaint system and the proper review and handling of consumer complaints.
? Work closely with Quality supervisors across all warehouses in Asia to ensure the implementation of high quality standards and systems in all countries (SOPs, Cleaning & Sanitization, Storage conditions, Documentaion, etc..).
? Analyzing and reporting data from quality metrics. The incumbent analyzes quality metrics to proactively identify trends before they become regulatory or serious quality/supply issues. The incumbent works with the GMP sites to investigate serious matters including high or increasing levels complaints, deviations, CAPAs to assuring the root causes are identified and corrected
? Providing on-site support, for instance during regulatory inspections, to assure clear communications to and support from Global QA.When necessary providing hands-on support to complete investigations into potentially serious matters. Assigning individuals to work directly at the manufacturing or distribution sites when needed to supplement capabilities and capacities of local personnel and to assure that critical activities are handled efficiently.
? Participates with the sites before, during and after regulatory inspections to assure acceptable results and full transparency with headquarter including senior company management levels. Assists that all observations made during audits and regulatory inspections are addressed in a timely manner and meet all company and regulatory requirements and that the responses to the regulators show the company in a true and positive manner.
? Provides management and direction for all aspects of the manufacturing quality program, including compliance, corrective action, setting future direction.
? Assures the proper review and handling of all regulated documentation.
? Acts as the main point contact with inspections by Competent/Regulatory authorities within the ASEAN region and the preparation and implementation of corrective action plans subsequent to such visits.
? Attends continuing education seminars to stay abreast of current regulations & requirements.
? Performs other duties as assigned or needed.
? Ability to travel within Asia and to US as needed.

Qualifications
? B.S. in Chemistry, Biology, Microbiology, Engineering or closely related field. Advanced degree desirable.
? > 10 years of professional experience in Manufacturing, Quality Control and Quality Management, ideally in a Food or Supplement manufacturing environment.
? Superior leadership skills.
? Ability to analyze problems and create solutions.
? Ability to work under stress on multiple tasks in a fast-paced work environment.
? Ability to work independently and professionally in all situations.
? Excellent written and verbal communication skills in Chinese and English.
? Excellent math skills (add, subtract, multiply, divide, analyze, etc.).
? Visually read reports, computer screen, etc.
? Ability to perform the essential duties and responsibilities with efficiency and accuracy.
? Pharmaceutical manufacturing, regulatory compliance and quality control laboratory technologies
? In-depth knowledge of suppplement quality assurance compliance systems (i.e., at least with GMP), global regulatory compliance standards, and current enforcement trends.
? Technical awareness and understanding of pharmaceutical testing and manufacturing processes/equipment commonly utilized for the production of drug products and active pharmaceutical ingredients.
? Subject matter expertise in Pharmaceutical, or Food quality assurance operation. 举报 分享

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