Quality Systems Manager

Found in: beBee S CN - 4 weeks ago

Hangzhou, China Abbott Laboratories Full time

MAIN PURPOSE OF ROLE

The primary objectives of the Quality Assurance Supervisor are to develop, facilitate, implement, and maintain the effectiveness of the quality systems for pilot plant operations in the Asia region, including the Process Research Lab (PRL). Provide Quality Assurance input to engineering projects, best practice initiatives, and validation protocol development.

MAIN RESPONSIBILITIES

  • Responsible for implementing and maintaining the effectiveness of the quality system and for providing Quality Assurance design review support to product development projects.
  • Develop systems to track, trend, report and reduce nonconforming situations.
  • Support the resolution and approvals of exception reports and manage the identified corrective and preventive action plans for all nonconformities.
  • In conjunction with the regional Compliance Manager, develop and maintain the annual internal audit program schedule. Coordinate and perform Internal and GMP audits as per schedule.
  • Audit validation packages, maintenance work orders and other related documents that may be subject to Corporate or Regulatory audits.
  • Manage the documentation system and requirements for assigned operations. Ensure all QA documents meet established divisional, corporate and regulatory requirements, and are current and up to date.
  • Identifies any gaps in the documentation system and take necessary actions to correct and improve. Develop and improve on the documentation routing process to assure timely implementation or requested changes.
  • Manage the Quality Management Review process for the assigned operations group, and follow up on all items assigned during Management Review meetings as well as special projects as assigned.
  • Be the main point of contact with groups outside of R&D, such as Medical, Regulatory, etc.
  • Understand and apply industry regulations knowledge with an understanding of the business operation to achieve regulatory compliance.
  • Conducts performance reviews, develop growth plans and implements and support employee-related policies, procedures and programs. Assigns projects and task to direct staff.  May lead of team of 2-3 direct reports

QUALIFICATIONS

Education

  • Bachelors Degree (± 16 years)
  • Technical Field such as Engineering, Chemistry, Pharmacy, Biology or Microbiology or equivalent experience

Experience/Background

  • Possess a thorough knowledge of Quality Assurance and Manufacturing processes (production, logistics, engineering and performance metrics).
  • Possess technical understanding of different technologies, manufacturing quality systems and Clinical Operations and is able to provide consultation and recommendations to help improve compliance. Prior experience in pilot plant operations would be highly desirable.
  • Have experience in documentation review, for documentation control and for batch release purposes.
  • Have experience in performing/leading audits and working independently through troubleshooting issues.
  • Ability to successfully interact and communicate with all organizational levels internally and externally.
  • Demonstrate the ability to manage several activities / projects at once, to organize / prioritize work, to meet deadlines and to prepare plans and reports.
  • At least 8 years of relevant QA experience in a regulated environment such as MEDICAL DEVICE is preferred.

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