Kelly Services is currently seeking a GCP Auditor for a long-term engagement with one of our Global Pharmaceutical clients. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Main objectives related to this activity is to support the IRIS R&D QA Audit Group on the conduct of GCP audits as described on the annual audit program. According to the qualification of the selected candidate the audit perimeter can be extended.
GCP Audits preparation, conduct, reporting
Prepare, conduct, report GCP Audits (ie., Investigator site audit, Trial Master Files audits, CRO or Vendors qualification/follow-up audits, System audits)
Analyze and monitor the key performance indicators of quality audits and share the analysis with the Quality Management System (QMS) team and any other relevant business
GCP Audit Responses Follow-up
Advise and support the audited structures (e.g., investigator site, CROs or vendors, study team) in the development and implementation of corrective and preventive actions (CAPAs) to ensure compliance with regulatory requirements and internal procedures.
Approve corrective and preventive actions (CAPA) related to audits and if applicable, follow up until the audit closure
May participate in the preparation of inspections at site or sponsor level
May participate during the inspection as a note taker and help the staff in the response to inspectors
May Participate in the development and follow-up of the inspection responses
May participate in the development of the audit program for the molecule (s) under his or her responsibilities
Interacts with the QMS Project Team Member
Participate in the inspection strategy preparation for the molecule (s) under his or her responsibilities
Participate in the outsourcing of GCP Audits by drafting the specifications, review of Requests for proposal, subcontractor selection, planning the activities of the subcontractor
Pharmacist (Pharm D), PHD, or Master of science and specific Quality Assurance training. MD a plus.
Minimum of 7-10 years’ experience in a quality assurance or related role including experience on GCP audit conduct.
Knowledge of applicable regulations to GCP perimeter.
Knowledge of applicable regulations to GVP and previous experience on GVP audits will be a plus.
Previous experience within pharmaceutical companies and/or Competent Authorities. Language: English. Other speaking language is a plus.
Proactive to predict issues and solve problems, Ability to establish excellent working relationships.
Excellent planning and prioritization skills.
Strong capacities to work transversally in an international environment.
Work from home but must be located in EST due to timing for calls outside of the US.
Ability to travel US and international
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