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QA Supervisor (Wuhan)

Job Responsibilities

  1. Principal Duties and Responsibilities Participate in the daily activities of the QA Department as assigned.
  2. Establish and maintain quality system to ensure the manufacture, testing and distribution processes comply with applicable regulatory requirements.
  3. Lead or participate in the internal auditing program for JHL Wuhan China, as required. Also supporting regulatory, client and third party supplier audits.
  4. Lead or participate in the execution of the product compliant system and assist with product return, withdrawal or recall activities as required.
  5. Oversee compliance of the environmental monitoring and validation program.
  6. Operational execution of key elements of the quality system-including document control, change control, CAPA, to maintain compliance with GMP and international regulatory requirements.
  7. Writing or reviewing completed quality system documents.
  8. Provide QA input on GMP facility and GMP utilities issues such as qualifications/requalification, changes, maintenance, startup/shutdown, disaster recovery.
  9. Writing or reviewing validation protocols such as IQ, OQ and PQ to support new production equipment installation.
  10. Review and approval of data for determining the disposition of GMP material (raw material, in-process, drug substance, finished product, packaging, labeling and manufacturing components) and the review and approval of documents and data associated with the stability program.
  11. Conduct GMP training for internal functional department.

Job Qualifications (Education, Certifications, Experience)

  1. BS degree and above, scientific discipline preferred.
  2. At least 5 years experience in a quality regulated industry, pharmaceutical or medical device experience is preferred, QC experience and regulatory submission experience in China is a plus.
  3. At least 2 years in a GMP quality system QA role.
  4. Proficiency in the use of all Microsoft office applications.
  5. Demonstrated leadership experience with personnel management, development and accountability
  6. Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines. Well organized and detail oriented professional.
  7. In-depth knowledge of GMPs and related guidelines and regulatory requirements.
  8. Good oral and written communication skills in English and Mandarin. (Read, Write, Verbal) demonstrated by communicating effectively with other functions and management processes within quality assurance and multi-disciplinary teams.