### **QUALIFICATION ANALYST** ### **About Abbott** ### **Abbott is a global leader in healthcare, creating innovative science to improve people's health. We are always looking ahead, anticipating changes in medical science and technology.** ### **Working at Abbott** ### **At Abbott, you can do work that makes an impact, grow and learn, take care of yourself and your family, be truly who you are, and live a fulfilling life. You will have access to:** * ### **Professional development with an international company where you can achieve the career you dream of.** * ### **A company recognized as a top workplace in dozens of countries around the world and named one of the most admired companies by Fortune magazine.** * ### **A company recognized as one of the best large workplaces for working mothers, female executives, and scientists, and where diversity is valued.** ### **The Opportunity** ### **This position is located in Cali within the Established Pharmaceutical Products division, in the Research and Development area. We are committed to delivering the benefits of our reliable medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality, differentiated branded generic medicines spans multiple therapeutic areas, including gastroenterology, women’s health, cardiometabolic, pain management / central nervous system, and respiratory pathways. As a Qualification Analyst, you will perform technical activities related to defining process measurements for validation and qualification projects, as well as carrying out these measurements.** ### **What You Will Do:** * ### **Support the validation coordinator in general work plans based on guidelines established in the Validation Master Plan, manuals, and related procedures.** * ### **Work with the validation coordinator to develop activity schedules based on information provided by Research and Development, Planning, Production, Regulatory Affairs, and Management guidelines.** * ### **Work with the validation coordinator to keep manuals, procedures, instructions, and formats applicable to the qualification and validation process updated according to company needs.** * ### **Analyze and implement improvements to existing processes, including corresponding procedures, guidelines, and forms.** * ### **Conduct audits and inspections of processes and identify improvement opportunities.** * ### **Establish tracking tools with the validation coordinator for performed activities as indicators of progress in validation programs.** * ### **Coordinate with the validation coordinator and development, planning, and production departments the scheduling of critical support equipment and systems required for validation program activities.** * ### **Collect information regarding each unit operation of the processes being monitored for validation. Document and tabulate results from various tests conducted. Coordinate and participate in different activities described in individual validation plans with process leaders.** * ### **Standardize and disseminate documents used and generated during process validation activities.** * ### **Develop appropriate test plans according to the qualification and/or validation stage.** * ### **Prepare risk assessments, protocols, reports, and annexes for each assigned qualification and validation, and manage the validation dossier compiling all relevant information from creation through digitization and archiving.** * ### **Coordinate with the validation coordinator the various computerized system validation programs according to the general plan and execute defined validation challenges with support from the systems team.** * ### **Coordinate and participate in the development of critical qualification and/or validation activities such as those related to air systems (HVAC), potable water, purified water, water for injection, pure steam, nitrogen, compressed air, computerized systems, cold chain, transportation, thermal mapping, manufacturing equipment, and other requirements from the area.** * ### **Review and analyze results obtained from qualification activities of air systems (HVAC), potable water, purified water, water for injection, pure steam, nitrogen, compressed air, computerized systems, cold chain, transportation, thermal mapping, manufacturing equipment, and other requirements from the area.** * ### **Report findings or deviations identified during qualification and validation processes so that required corrective and preventive actions can be taken.** * ### **Participate in investigations associated with non-conformances and/or deviations arising from Validation and Qualification programs for Critical Support Systems and equipment.** * ### **Follow up on the closure of non-conformances, deviations, and change controls originated or impacted by Equipment and System Qualification and Validation.** ### **Required Qualifications** * ### **Professional degree in Pharmaceutical Chemistry, Chemistry, or Engineering fields** * ### **EXPERIENCE IN POSITION: 1.5 to 3 years** ### **Preferred Qualifications** * ### **Equipment qualification** ### **Apply Now** ### ### **Pursue your professional aspirations with Abbott to gain diverse opportunities with a company that can help you build your future and live your best life. Abbott is an equal opportunity employer committed to workforce diversity.** ### **Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews and @AbbottGlobal.**