QA Global Audit Manager Moen
Abbott
Florencio Varela,Argentina
hace 15 días

JOB DESCRIPTION :

The role of the QA Manager Global Audit and Due Diligence is to manage the evaluation of Global Suppliers, Third Party Manufacturers, and internal locations via the supplier and internal audit program.

As experienced senior auditor, responsible for continuous improvement initiatives, global quality projects, auditor training program, risk assessments and due diligence audits / projects as applicable.

The individual may function as the primary Quality Lead for assigned global product acquisition and in-licensing deals. Additionally, support on company acquisition due diligence activities is performed as assigned.

Minimum Education

Bachelor Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical / scientific area

Minimum Experience / Knowledge Required

  • At least 10 years in the Pharmaceutical Industry and / or Government Regulatory Agency; and 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 the EU, FDA, PICs, WHO and other relevant GMP and ICH guidelines and regulations.
  • General knowledge of technical, chemical and pharmaceutical processes, validation procedures and analytical methodology,
  • Capable of understanding and overcoming different cultural and language obstacles to provide solution that satisfy, corporate, regional and local objectives.
  • Capable of analyzing data in in order to support the development of strategies to effectively manage the action plans that will resolve the issues.
  • Excellent verbal and written communication skills in Business English
  • Excellent project management skills.
  • Excellent knowledge of data integrity regulations and requirements
  • JOB FAMILY : Quality Assurance

    DIVISION : EPD Established Pharma

    LOCATION : Argentina >

    Argentina >

    Florencio Varela : Manufacturing Building

    ADDITIONAL LOCATIONS : WORK SHIFT :

    WORK SHIFT : Standard

    TRAVEL : Yes, 50 % of the Time

    MEDICAL SURVEILLANCE : Not Applicable

    Not Applicable

    SIGNIFICANT WORK ACTIVITIES :

    Not Applicable

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