QA Deviations

Job Description

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Job Summary

The QA Deviations and Complaints Specialist of the Quality Support Center (QSC) , assists with the coordination of the Deviation and Complaints Program in alignment with appliable healthcare guidelines (e.g., cGMP guidelines) and ISO 9001/ISO 13485 standards. He/She maintains knowledge of healthcare quality regulation(s) and assess the impact associated with the storage and transportation of healthcare products by communicating concerns to the next level of management. In this role, he/she provides support to field QA with initiation of investigation for deviations and customer complaints and drafting of action plans in the respective facilities as the deviation and customer complaints subject matter expert (SME).

Other Duties

Support his/her Management with the coordination of tasks, design, impact, and/or continuous improvement of the Deviation & Complaints Program. Support his/ her Management with the development and maintenance of deviations, customer complaints procedures in in accordance with applicable healthcare regulations (e.g., GDP, cGMP) and ISO 9001/ ISO 13495 standards. Initiates the investigation and development of deviations and customer complaints by providing direction for facilitation of improvements on identified risks to field QA. Initiates, assesses, and documentation of deviations and complaints in the electronic Quality Management System (eQMS). Tracks action plans to closure and reports late/delayed action plans to the next level of management. Provides data and supports quality management system reviews for area(s) of responsibilities.

Preferred Competencies

Experience with healthcare regulations (e.g., cGMP, GDP, GMP) guidelines is preferred. Experience with ISO 9001 and ISO 13485 standards is an advantage. Advanced English Knowledge of Quality Management System is an advantage. Knowledge of Microsoft Office (Excel, Word, Outlook, Access). Captures/documents specific and accurate information; learns subjects thoroughly and in detail; completes work with thoroughness; supplies appropriate details when requested; maintains organized files. Identify potential gaps in the processes and make recommendations for possible improvements. Strong time management skill, able to work within time-limits (deadlines)

MINIMUM QUALIFICATIONS

Bachelor's Degree (or internationally comparable degree) – Preferred Bachelor's Degree (or internationally comparable degree) – Science or related discipline

Grade: 10C

Location: Bogota

Deadline to apply: Monday 17th June, 2024.

Employee Type:

Permanent

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