Job Description
Job Summary
QA Supplier Management and Validation Specialist for the Quality Support Center (QSC) assists with the implementation and maintenance of the Quality Management System within the scope of the supplier qualification process and computer system validation (CSV) in alignment with healthcare guidelines (e.
g., GDP, GMP, cGMP) and ISO 9001 / ISO 13485 requirements. He / She provides support with the implementation of the Supplier Management Program and participates in the qualification process of the suppliers.
In addition, he / she assists with the identification of systems requiring validation, elevates validation issues appropriately, and provides validation expertise.
Other Duties
- Contribute to the development, maintenance, and continuous improvement of the Supplier Management & CSV Programs.
- Conduct risk assessments on the Supplier Management process to identify potential risks, summarize and communicate findings to their next level of management.
- Assist with the distribution, follow-up, and evaluation of the supplier questionnaires.
- Prepares and executes Supplier audits according to the created Supplier audit plan and Supplier risk levels.
- Monitor and trend the outcome of the Supplier audit findings.
- Assist with the distribution and completion of Supplier Technical Agreements.
- Assists in the development and revision of procedures (e.g., change control, training, audits) to ensure the alignment to regulatory acceptable guidelines.
- Assists in the development, execution, and reviews of validation protocols.
Preferred Competencies
- Experience with healthcare regulations (e.g., cGMP, GDP, GMP, GAMP) 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 Preferred
Grade :
10C
Location : Bogotá
Deadline to apply : Monday 17th June, 2024
Employee Type : Permanent
Permanent
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