Description
Job Summary:
Verify compliance with Good Manufacturing Practices (GMP) and internal procedures to ensure process reproducibility and continuous improvement.
Key Highlights:
1. Committed to improving the lives of patients with chronic kidney disease.
2. Part of a global team of more than 110,000 colleagues.
3. Opportunities for professional development and career planning.
At Fresenius Medical Care, we are global leaders in renal care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver innovative, high-quality products, services, and care across the entire patient health journey. Guided by our vision — “Creating a future worth living. For patients. Around the world. Every day.” — we act with purpose and compassion, supported by a global team of more than 110\.000 colleagues.
At our Bogotá, Colombia facility, we specialize in the production and distribution of a broad range of high-quality products essential for dialysis therapy and patient care. We manufacture HD and PD solutions, disposables, intravenous solutions, and Biofine empty bags. Additionally, we distribute the full dialysis portfolio, including pharmaceuticals, dialyzers, blood lines, and dialysis machines.
The Bogotá team plays a vital role in Fresenius Medical Care’s commitment to advancing patient care worldwide.
Join our passionate team and be part of this global impact!
Our values guide how we work:
* We care for our patients, each other, and our communities.
* We connect teams and borders to deliver excellence together.
* We commit to doing things right — growing with purpose and leading renal care with integrity and innovation.
**Quality Inspector**
**Location:** Vía Siberia\-Funza in Intexzona Free Trade Zone, On-site
**About the Role:**
Verify compliance with Good Manufacturing Practices (GMP) and internal manufacturing procedures (SOPs) at the Production Plant and Distribution Center to ensure process reproducibility and continuous improvement. Lead compliance with Good Manufacturing Practices (GMP) and internal manufacturing procedures (SOPs) at the Production Plant and Distribution Center to ensure process reproducibility and continuous improvement.
**Key Responsibilities:**
* Verify compliance with applicable procedures at the Production Plant and Distribution Center.
* Verify correct completion of records generated at the Production Plant and Distribution Center.
* Verify adherence to Good Manufacturing Practices (GMP) at the Production Plant and Distribution Center.
* Verify conformance of production and/or storage stages, documenting each inspection in its corresponding record.
* Manage retained product samples and maintain the electronic sample archive up to date.
* Ensure accurate documentation of production processes in the manufacturing records generated and completed at the Production Plant.
**Requirements:**
* Bachelor’s degree in Pharmaceutical Chemistry, Chemical Engineering, Chemistry, Microbiology, or related fields.
* Knowledge of current Good Manufacturing Practices (GMP).
* Knowledge of Internal GMP Auditing per Resolution 1160 of 2016\. (Desirable).
* Proficiency in Microsoft Office suite.
* SAP experience.
* Intermediate English proficiency.
* \+2 years of experience in Quality Assurance, Inspection, and/or supervision of production or logistics processes.
**What We Offer You:**
There is much to discover at Fresenius Medical Care — regardless of your area of expertise or level of experience — all focused on your professional development.
Whether on the front line or behind the scenes, your contribution helps make increasingly better medicine available to a growing number of people worldwide.
* Individual opportunities for autonomous career planning and professional development.
* A corporate culture that encourages innovative thinking — so together we find the best solution, not just the fastest one.
* A large number of dedicated individuals with diverse competencies, talents, and experiences.
* The benefits of a successful global organization, combined with the collaborative culture of a mid-sized company.