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QA Specialist - China  

Company managed [?] Still accepting applications

Posted on : 12 August 2017

Project Description

34887
QA Specialist
上海
Shanghai
China
Primary Function
To assist QA Manager to conduct QA oversight within Wusi site, review and approve GMP documents, e.g. changes, batch records etc., to ensure that all aspects of manufacturing activities comply with cGMP legal and regulatory requirements and with Elanco Quality Standards.
Primary Accountabilities/Responsibilities
  1. Perform review of GMP related documents (formulation/synthesis batch records, analytical record, etc.) to ensure batch release timely.
  2. Recognize complex deficiencies in GMP documents, report them to QA&QC manager, chemist or supervisor, suggest actions and supervise agreed follow-up. Propose and survey implementation of agreed preventive actions.
  3. Perform supplier management, including supplier list maintenance, QAA, Supplier performance review and supplier audit follow-up etc.
  4. Manage and oversee pest control, environment, gases and water system monitoring activities.
  5. Timely write and complete GMP relevant documents in own area: e.g. APRs/PQRs, annual environmental monitoring data review, annual site training review etc.
  6. Conduct on-site QA inspection for synthesis/formulation production and line clearance check.
Timely perform container wise ID test.Primary Function
To assist QA Manager to conduct QA oversight within Wusi site, review and approve GMP documents, e.g. changes, batch records etc., to ensure that all aspects of manufacturing activities comply with cGMP legal and regulatory requirements and with Elanco Quality Standards.
Primary Accountabilities/Responsibilities
  1. Perform review of GMP related documents (formulation/synthesis batch records, analytical record, etc.) to ensure batch release timely.
  2. Recognize complex deficiencies in GMP documents, report them to QA&QC manager, chemist or supervisor, suggest actions and supervise agreed follow-up. Propose and survey implementation of agreed preventive actions.
  3. Perform supplier management, including supplier list maintenance, QAA, Supplier performance review and supplier audit follow-up etc.
  4. Manage and oversee pest control, environment, gases and water system monitoring activities.
  5. Timely write and complete GMP relevant documents in own area: e.g. APRs/PQRs, annual environmental monitoring data review, annual site training review etc.
  6. Conduct on-site QA inspection for synthesis/formulation production and line clearance check.
Timely perform container wise ID test. 34887BR
Qualification
  • BS degree in Chemistry, Pharmacy or relevant discipline, MS Desirable
  • BS with at least 3 years of experience or MS with at least 1 year experience in pharmaceutical or relevant industry (e.g. laboratory, manufacture, packaging).
  • Prior experience in QA role for API manufacturing and formulation is a plus.

Skills & Knowledge

  • Fluent in English and Chinese (both written and spoken).
  • Excellent interpersonal skills and able to network effectively across groups and levels.
  • Ability to work under pressure and compliance with strict deadlines.
  • Ability to priorities or work with conflicting priorities.
  • Advanced knowledge of MS Excel, Word, PowerPoint.

Core competencies

  • Influence: Builds relationships and influences internal and external customers, Team player.
  • Accountability: Accountable for Results, Good multiple-tasking focus, Strong follow through and closure of matter/case.
  • Working Style: Persistence and Stability, Results Orientation, High learning agility, Proactive and fast response/having sense of urgency, , Attention to details and adherence to guidelines.
  • Personal Brand: Resourceful, Assertive, Self-motivated, Energetic.

Other Information

1. Location: Wusi Site