Quality Assurance Coordinator

Description

Job Summary: Ensure compliance with local laws and quality standards for handling pharmaceutical products and coordinate compliance with GMP, GDP, and GDocP. Key Responsibilities: 1. Ensure and monitor compliance with laws and quality standards. 2. Coordinate compliance with Good Practices (GMP, GDP, GDocP). 3. Lead internal and external audits and implement improvements. **POSITION:** 1, Quality Assurance Coordinator **LOCATION:** Funza, San Carlos II **PURPOSE:** Ensure and monitor compliance with local laws regarding storage and handling of pharmaceutical products, as well as dispensing and sampling activities for raw materials and packaging materials, to meet internally established and/or customer-defined quality standards. Coordinate that storage, secondary packaging, dispensing, and sampling areas comply with GMP (Good Manufacturing Practices), GDP (Good Distribution Practices), GDocP (Good Documentation Practices), and applicable regulations covering all processes related to handling, storage, or processing of products: Pharmaceuticals, Cosmetics, Medical Devices, Food, Veterinary Products, Raw Materials, Packaging Materials, Natural Products, and any health-related products in Colombia; Life Science and Health Care products; and other products required to be stored at IWS Colombia sites. **RESPONSIBILITIES** * Authorize and approve written procedures and other process documents for raw material and packaging material storage, dispensing, and sampling—including revisions. * Develop the raw material and packaging material sampling and dispensing plan. * Review and approve sampling orders (Sampling and Dispensing Certificate). * Monitor and control environmental conditions in raw material and packaging material storage, dispensing, and sampling areas. * Ensure proper execution of hygiene and cleaning procedures in storage, dispensing, and sampling areas. * Ensure implementation of validation and calibration programs for analytical instruments used in dispensing and sampling areas. * Train new personnel and ensure continuous training for staff involved in raw material and packaging material storage, dispensing, and sampling processes, as well as in quality assurance principles. * Monitor and evaluate transformation/secondary packaging, dispensing, and sampling processes for raw materials and packaging materials. * Follow up on good documentation practices to maintain record quality. * Ensure that raw material and packaging material storage, dispensing, and sampling records are reviewed and signed by designated personnel. * Participate in approving any outsourced activity that may impact good storage, dispensing, and sampling practices for raw materials and packaging materials. * Identify and implement improvement opportunities in secondary packaging, storage, dispensing, and sampling processes for raw materials and packaging materials. * Maintain valid regulatory and quality certifications enabling proper operational functionality. * Respond to and lead audits conducted by internal or external customers and local regulatory authorities, where Quality is within scope. * Prepare and follow up on action plans resulting from each internal or external audit **SKILLS AND COMPETENCIES:** * Problem Analysis: Ability to identify a problem and relevant data, recognize pertinent information, and possible root causes. * Numerical Analysis: Ability to analyze, organize, and resolve numerical issues, financial data, statistics, and similar information. * Critical Thinking: Ability to evaluate data and alternative courses of action to make logical, impartial, and reasoned decisions. * Planning and Organization: Ability to effectively develop an appropriate personal or third-party action plan to achieve an objective. * Teamwork: Willingness to participate as an integrated team member (two or more people) to achieve a shared benefit resulting from the task performed, irrespective of personal interests