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Quality Coordinator

hace 1 mes

Bogotá Cundinamarca, Colombia Cencora A tiempo completo

**Job Details**:
**OSITION SUMMARY**:
This role, as a quality representative plays a crucial role in ensuring compliance with World Courier policies and procedures. They are responsible for overseeing quality-related activities within the CSS and transport divisions of the organization. They provide guidance to offices and divisional associates on matters of quality and compliance.

**Tasks and Key areas of responsibility**

**1)** **Quality Management System (QMS)**

a) **QMS Management**: Developing and maintaining a robust QMS that defines the organization's quality objectives, policies, procedures, and performance metrics. This includes to act as a first contact for the Country Manager and local team for quality related topics. And to ensure that quality aspects for CCS and Transport are adequatly represented during local and global meetings as well as local and global projects and initiatives. Organize and support management review meetings in accordance to applicable SOP.

c) **Quality Agreements**: To review and negotiate quality agreements and Confidentiality Disclosure Agreements (CDAs/NDAs). This includes carefully examining the terms and conditions outlined in these agreements, ensuring alignment with company policies and regulatory requirements.

d) **Internal / External Audits, Inspections and certification audits**: To be the main auditor contact and to communicate with relevant parties within the organization. To initiate and oversee the audit organization. Respond promptly to auditor inquiries by providing accurate information, supporting documentation, or clarification as needed. Work with management teams to develop and follow up action plans for addressing any identified non-compliance issues and provide audit responses in due time.

e) **Incident Management**: Review and manage the documentation on incidents. Actively participating in investigations on non-conformities or deviations from established quality standards. Provide quality input for investigations, root cause analysis and CAPA and support corrective and preventive action initiatives to address root causes. Assisting in the creation of comprehensive reports, and diligently monitoring deviations and subsequent actions as outlined in the specific internal guidelines. Reporting to global QA and local leadership any deviations or potential problems. Ensuring that relevant customer complaints are dealt with effectively.

f) **Risk Management and Change Control**: Assist in setting up and to participate in Risk Management and Change Control processes. To ensure that clients are contacted whenever required in order to communicate changes such as but not limited to expansions, depot moving process, regulatory updates clarifications, etc.

g) **Technical Quality Support**: Overview and verify technical change controls, calibration, maintenance and qualification / validation program according to internal guidelines, supporting the local facility representative and QA manager technical compliance.

h) **Documentation Management**: Ensuring accurate documentation of all quality-related activities such as SOPs, work instructions, test records, audit reports, etc. This also includes to organize regular reviews of, e.g. Local Standard Operating Procedures (SOPs) and Work Instructions (WIs) with the process owner / author. To support the review of these documents to ensure that they align with established service standards as well as quality and regulatory requirements.

i) **Quality Data Management**: To execute all tasks using dedicated software tools such as Master Control and SharePoint (or other applicable software tools). This includes accurately inputting and timely updating data, attaching relevant documents, tracking progress, documenting actions taken, and adhering to any specific workflows or process as outlined in the standard operating procedures.

**2)** **Compliance Assurance**
- Ensuring compliance with relevant regulations (local law, GDP, quality regulations etc), industry standards (such as ISO and relevant GxP standards), customer requirements, and internal policies. Staying up-to-date with changes in regulations and triggering / implementing necessary QMS changes.
- Verifying adherence of World Courier employees to all Company Policies and Procedures as applicable to their role and responsibilities through effective monitoring, guidance, and support during standard process implementation.
- Ensure that World Courier License(s) as well as any other regulatory documentation is/are properly in place and updated as applicable

**3) Quality Training and Education**

a) **Training Program**:Developing training programs to educate employees on quality standards, quality processes, and quality techniques. Ensuring that initial and continuous training programs are implemented and maintained related to Good Documentation, Good Manufacturing, Good Distribution and Good Clinical Practices (when applicable).

b) **Internal Guidelines T