WuXi AppTec Quality Assurance Audit Lead in Philadelphia, Pennsylvania
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.
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
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.
Job ID: 2017-3012
External Company Name: WuXi AppTec Inc
External Company URL: http://wuxiapptec.com