17 ene
Johnson & Johnson
Ciudad Juárez
.Senior Regulatory Compliance SpecialistAt Johnson & Johnson, the largest healthcare company in the world, we come together with one purpose: to profoundly change the trajectory of health for humanity.Diversity & Inclusion are essential to continue building our history of pioneering and innovation, which has been impacting the health of more than 1 billion patients and consumers every day for more than 130 years.
Regardless of your race, belief, sexual orientation, religion or any other trait, YOU are welcome in all open positions at the largest healthcare company in the world.When You Join Johnson & Johnson, Your Next Move Could Mean Our Next Breakthrough.
**COMPANY****JOB RESUME**Conducts audits— planned and unplanned — to verify compliance with government regulations and applicable standards, in addition to company policies and procedures.
Give guidance or advice to the organization as it relates to compliance, when required.
**RESPONSIBILITIES**Under general direction and in accordance with all federal, state, and local laws/regulations and procedures andguidelines of the Johnson & Johnson Corporation, this position:- Ensures that Quality System Audits comply with the requirements of QSR/GMP and ISO Standards- Conducts internal audits of the Quality System for the purpose of verifying compliance with governmentregulations and applicable standards, in addition to company policies and procedures.
Conducts goodlaboratory practice (GLP) audits as required.- Gives guidance or advice as it relates to compliance with applicable standards and regulations.- Performs re-audits to deficient aspects and to implement corrective and preventive actions as necessary and required.- Assigns classifications to internal audit observations and documents audit results in written reports that canbe distributed and reviewed by appropriate management.- Monitors the effectiveness of corrective actions documented in observation responses.- He/She can be the lead auditor of a team of auditors, technical experts, auditors-in-training, and/orvolunteer auditors.- Reviews ownership of responses to audit observations, also acts as an advisor to other areas that are not being audited by him/her, giving advice on audit observation responses.- Maintains audit report files, re-audit files and responses to audits carried out.- Accompanies external auditors, representatives of government agencies or those required by management during the execution of an applicable audit.- Conducts audits at other J&J; sites when required by management.- Complies with and reviews compliance metrics and communicates them to site management and theFranchise.
Prepares information for Management review boards.- Participates in the formulation of Regulatory Policies and Procedures in compliance with applicable local,state and federal standards and regulations through the development of Franchise Documents
Muestra tus habilidades a la empresa, rellenar el formulario y deja un toque personal en la carta, ayudará el reclutador en la elección del candidato.