天津招聘

职位描述：
The candidate should be experienced in GMP-related food, cosmetics, and/or household products.

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

Here's the JD:

Responsibilities
? Coordinates internal audits of plant(s) for compliance to Regional (Asian) and country specific GMP laws and internal procedures.
? Coordinates vendor audits to assess their ability to comply with company specifications and meet GMP requirements.
? Assists Regional QA manager during Regulatory Authority Inspections and other agency inspections.
? Coordinates the audit of documentation and recommends document changes for the plant.
? Assist consumer complaints specialist in researching possible causes and provides feedback regarding product quality issues raised by the consumer.
? Keeps current on regulatory actions in the Drug industry.
? Writes internal and vendor audit reports.
? Works with vendors and purchasing to assure continuing conformance to specifications of incoming labels, components, ingredients, and outside-manufactured products.
? Keeps current on QA inspection results and procedures.
? Performs routine audits on historical batch records and other past OTC documentation.
? Coordinates the yearly GMP awareness and compliance training.
? Develops Corrective and Preventative action plans (CAPA) with internal plant and warehouse supervisors and ensure implementation in a timely manner.

Requirements
? Bachelor’s degree with 3 years manufacturing industry experience with at least 3 years experience with Quality Audits or working with vendors.
? ASQ Auditor or Auditor Certification.
? A working knowledge of Regional Competent Authority Regulations regarding the manufacturing and distribution of food and supplement products.
? Experience with quality system audits.
? Self starter.
? Excellent verbal and presentation skills. Very good English communication skills.
? Ability to organize and coordinate projects.
? Ability to travel within Asia.
? Ability to write meaningful, accurate, and concise reports.
? Ability to perform multiple tasks in a fast paced setting.
? Computer word processing, spreadsheet, and database skills.
? Experience in dealing with regulatory agencies such as KFDA, CFDA or SFDA.
? Pharmaceutical manufacturing, regulatory compliance and quality control laboratory technologies
? In-depth knowledge of pharmaceutical 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 quality assurance operation.
? Ability to represent company in a positive manner, personally and professionally, to regulatory agencies, vendors, and outside contacts. 举报 分享

We are a professional recruitment company hiring full-time roles for industry-leading MNCs in China.