• Compliance Manager Jobs in China - 23685328

  • Abbott India Ltd
  • China
  • Save Job
  • 10 - 13 Years
  • Posted : above 1 month

Job Description:

JOB DESCRIPTION Core Job Responsibilities

Maintain the CNAS-CL01 / ISO-IEC 17025 standard for the Analytical Research Lab Manage Act as primary contact point for the external quality agency (eg CNAS) on all audit matters
Schedule and lead Management Review of the site quality systems and KPIs Track all quality-related compliance commitments related to External, Corporate and Internal audits to closure timely Manage and guide all SOP Change Requests in Teamcenter for the R&D Center
Manage and guide Validation Change and Calirbation Control Requests for new or existing laboratory instrument/equipment used to generate quality data
Manage and guide quality events or noncompliance investigation, resolution and Exception Report documentation with initiators Tracking all corrections, corrective, preventive and effectiveness check items to closure timely Ensure site inspection readiness for the Analytical and Product Development Laboratories in the R&D center
Plan and/or conduct internal quality audits for the Analytical and Product Development labs in the R&D center Conduct New Hire Orientation to new personnel on Overview of Quality Systems and Job Specific Quality Requirements training
Provide quality guidance to the Scientists and Managers on interpretations of Abbott quality requirements and all quality compliance matters
Schedule and conduct periodic instructor-led refresher training on relevant and important quality topics eg Validation, Calibration, Documentation Practices, Data Integrity, CAPA etc for Scientists and Managers

REQUIREMENTS Bachelor of Science degree in Chemistry/Microbiology/Life Science/Food Technology/Dairy Technology
Professional certification or designation eg Certified Lead Auditor or Certified Quality Engineer etc, is preferred
5 years of experience as a Quality Manager Experience in implementation of Quality Systems
At least 10 years in the GMP/Food Manufacturing and Chemistry/Laboratory industry
At least 5 years of GxP auditing experience, with a minimum of 3 years as lead auditor, leading audits related to GMP, GDP or ISO
Strong knowledge and understanding of CNAS-CL01/06/07/10/31/52,CNAS-GL01/02/04/06/09/39 and CNAS-RL01/02, China FSMP and selective GB test methods regulations
Good knowledge of Quality Assurance, CAPA, Change Control, Validation, Data Integrity and Analytical methodology
Experience in handling regulatory and external audits
Capable of analyzing data in to support the development of strategies to effectively manage the action plans that will resolve the issues
Ability of methodical and objective evaluation and failure investigation
Good Leadership and Management Skills, including the ability to set goals, and provide positive and constructive feedback respectfully to build positive relationships and improve business results
Capable of understanding and overcoming different cultural and language obstacles to provide solution that satisfy, corporate, regional and local objectives
Ability to prioritize tasks to meet deadlines and work with team when help is needed
Ability to perform multi-tasking
Ability to work independently and with a sense of urgency
Self-motivated, strategic thinker who can also execute the details, if necessary

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Healthcare, Manufacturing/Industrial
Functional Area : Quality/Process Control
Role : Quality Assurance
Salary : As per Industry Standards
Deadline : 24th Mar 2020

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