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Sr Compliance Engineer

Req ID: J2279795

  • Ubicación
  • Categoría Riesgos y Garantias
  • Publicado jueves, 15 de julio de 2021
  • Tipo Tiempo completo

Descripción del Trabajo

JOB SUMMARY

The Compliance Engineer, under the supervision of Compliance Manager, will lead and maintain the internal audit program to help the site sustain a state of readiness to applicable regulatory requirements.

DUTIES & RESPONSIBILITIES

  • External inspection readiness and associated activities. Support site audit readiness activities to ensure inspection readiness at all time.

  • Support external audits: e.g. Notified Body, Ministry of Health country inspections, FDA, Jabil Corporate Audits for site.

  • Participate in audit preparation activities (auditor logistics, front room/back room arrangements, identifying/preparing SME's, etc.).

  • As required, assess the risk and applicability of audit observations from other Jabil facilities to determine impact to the site.

  • Support mock inspections as part of External Inspection Readiness activities.

  • Provide timely information to support the inspection process.

  • Internal Audit and Supplier Audit Program and Management Execution

  • Execute against established internal audit procedures.

  • Ensure adequate corrective actions for internal, external and supplier audit including investigations and corrective action plans, drive on-time completion of observation action plans, perform follow-up with observation owners, and perform effectiveness monitoring and closure.

  • Drive compliance and improvement in internal audit metrics.

  • Ensure quality system is periodically evaluated and audited and appropriate preventive/ corrective action is taken to meet the business and regulatory requirements.

  • Enterprise / Sector Support

  • Connect and collaborate with other regions compliance teams.

  • Create reports and communicate performance against metrics to key stakeholders.

  • Support implementation of new external standards/regulations for the site.

  • Interacts with other franchise facilities to exchange support, and resources aimed to attain common compliance objectives

  • Maintain current knowledge of regulatory changes through industry publications, seminars, professional affiliations and industry meetings.

  • Provide input into Site Management Reviews (e.g., internal audits.) to allow meaningful review.

  • Establish strong connection and collaboration with business partners at the site, (e.g. Quality Operations, Training, and Manufacturing).

  • Provide compliance education and training (QSR, ISO, GMPs) to the organization in support of overall educational strategies.

  • Support and promote the safety and environmental objectives of the facility. Comply with all environmental, safety and occupational health policies (i.e., ISO14001 & OSHAS 18001).

EXPERIENCE AND EDUCATION

  • University/Bachelors Degree or Equivalent The Associate Compliance Engineer

  • Requires 4-6 years related experience / Knowledge

KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS

  • Thorough knowledge of the Text document systems on Document Management System.

  • Good written and oral communication skills as well as report writing, presentation and training skills both in English and Spanish.

  • Good interpersonal skills; customer service oriented.

  • Previous experience in supervisory position preferred.

  • Knowledge of 21CFR 820, ISO 13485, MDD, CMDR and ANVISA preferred.

  • Knowledge of Good Manufacturing Practices (GMPs) and Quality System Regulations (QSRs) preferred.

  • Knowledge of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required. Experience with Microsoft Project is preferred.

  • Experience in leading and managing projects and milestones preferred.

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