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Senior QA Manager - Taiwan

USD70000 to USD900000 per annum + bonus + benefits


Senior QA Manager


Job Description
Provide QA oversight for Qualification and Validation activities at Manufacturing site with the following core responsibilities:

  • Setup/be part of the QA validation team to support all aspects of qualification and validation program, including qualification & re-qualification of process and testing equipment, manufacturing process, QC testing, shipping, etc.
  • Develop, review and approve validation and qualification strategies for manufacturing facility, processes, cleaning, shipping and equipment, including supporting risk assessments.
  • Provide QA expertise to assess impacts and support investigations, deviations, CAPAs related to validation / engineering processes.
  • Provide oversight for validation / engineering related cGMP documents including, but not limited to validation plans, SOPs, work instructions, templates, guidelines, protocols, summary reports and ensure consistency and compliance with regulatory requirements.
  • Review and approve facility and equipment related change controls, including the assessment for equipment criticality, calibration / PM program.
  • Create Validation Master Plan and ensuring that the Company’s Validation Master Plan is up to date, maintaining the validation life cycle of the manufacturing facility.
  • Manage site validation documentation program, validation vendor management and maintenance.
  • Provide leadership and guidance to staff on qualification / validation matters. Directs efforts to ensure efficient and effective systems are maintained and continuously improved.

Requirements

  • Degree and above in relevant subject
  • At least 5 years of experience in Quality Assurance and / or Compliance, including oversight for validation projects
  • Extensive knowledge of cGMP requirements, with working knowledge and understanding of Validation, Production, Quality Control requirements and activities
  • Strong working knowledge of US FDA and other equivalent regulatory requirements.
  • Mastery and knowledge of quality principles and cGMP guidelines.
  • Good understanding of validation principles and critical process parameters.
  • Good people management skills with ability to work cross-functionally.

Please send your resume in WORD format by clicking the apply button below or contact Jochen Surrey on +65 6701 1516 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1878834 (Jochen Nico Surrey).

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  • Táiwan
  • Permanent
  • Fri Oct 18 09:26:10 2019
  • BBBH7407