WuXi AppTec

Quality Assurance Audit Lead

US-PA-Philadelphia
Job ID
2017-3012

Overview

The primary Audit Lead’s function is to manage and participate in all facets of audits and inspections – client, regulatory, internal, external and vendor/supplier.  The position also provides support for the PHL QA and corporate QA operations and management to implement regulatory strategies and ensure regulatory compliance.

Responsibilities

  • Manage and conduct site client audits as directed by QA Management, to present overall quality systems and procedures, and handle audit responses in a satisfactory and timely manner.
  • Drive closure of CAPA resulting from audits.
  • Communicate with clients on compliance issues and corrective action surrounding PHL audits.
  • Participate in regulatory and accreditation audits and inspections as directed by QA Management.
  • Manage and conduct internal, external and vendor/supplier audits as directed by QA Management.
  • Participate in the development of site and corporate compliance policies, procedures and documents.
  • Assume a contributing role in compliance projects and participate in corporate and site strategic meetings.
  • Maintain knowledge of WuXi policies, procedures and directives as well as US and international regulations and guidelines associated with PHL services.
  • Performs other duties as required.
  • Participate in cross-site projects.
  • Provides back-up for the QA department in selected areas as needed.
  • Travels as required by the company

Qualifications

  • Thorough working knowledge of Regulatory Compliance, Quality System Management and Quality Assurance principles and practices.
  • Knowledge of FDA GLP/ cGMP requirements, FDA PTC guidelines required. 
  • Knowledge of EU cGMPs highly desirable.
  • Ability to write and revise documents.  Ability to use judgment in situations for which there are no precedents.
  • Experience in GLP and GMP.
  • Bachelors Degree or equivalent.

We are an Equal Opportunity Employer.  Minorities/Women/Veterans/Disabled.

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