HC QA Deviations

Job Description

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JOB DESCRIPTION:

The QA Deviations and Complaints Supervisor of the Quality Support Center (QSC) oversees the roles and responsibilities of the Deviations and Complaints Program, and ensure in alignment with healthcare guidelines (e.g., GDP, cGMP) and ISO 9001/ISO 13485 standards. He/She maintain knowledge of healthcare quality regulations and assesses associated risk with distribution and transportation of healthcare products, as appliable communicate findings to Sr. QA Management. As a subject matter expert (SME) of deviations and complaints, this role coordinates and supports the field Quality Team in the investigations, documentation, and corrective actions plan creation relating their area of responsibility.

Responsibilities and Duties

Develop and manage Deviations and Customer Complaints Program in alignment with UPS Healthcare quality policies and Standard Operating Procedures. Provide training, support, and developmental opportunities to direct reports. Coordinates the development and maintenance of Deviations (non-conformances) and Customer Complaints, procedures in in accordance with applicable healthcare guidelines (e.g., cGMP, EU GDP, EU GMP) and ISO 9001/ ISO 13495 standards. Coordinates the investigation and development of action plans for deviations and customer complaints by providing direction for facilitation of improvements. Consolidate, analyze, and identifies common trends for the Deviations & Complaints Programs. Present summary of findings, as applicable make recommendations to Senior leadership. Develops a system for identifying, continuous monitoring, analyzing and reviewing the Deviations and Customer Complaints Program. Supports management reviews for area of responsibilities. Provides direction and coordination to his/ her team and coordinates regular training(s) related to deviations (Non-conformance) and Complaints. Manages resources and people processes (e.g., Performance Management, Career Development, Training, Staffing, etc.) to ensure the day-to-day administration of processes and formal procedures. Manages reviews of policies, procedures, regulations, and specific work instructions with internal and external

Preferred Competencies

Knowledge of the different (Country) regulations and ISO 9001/ ISO 13485 standards is preferred. English Advanced Strong analytical and people management skills. Good knowledge of a Quality Management System and electronic Management System (eQMS). Good knowledge of Microsoft Office (Excel, Word, Outlook, Access). Ability to create networks and collaborate with various internal and external stakeholders. Ability to prioritize decisions which may have a significant risk for the company. 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 – Preferred A minimum of 3 years' experience in healthcare industry in a Quality role.

Grade: 20E

Location: Bogotá

Deadline to apply: Monday 17th June, 2024.

Employee Type:

Permanent

UPS is committed to providing a workplace free of discrimination, harassment, and retaliation.

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