Aline Carlos de OliveiraAO
Open to opportunities

Aline Carlos de Oliveira

@alinecarlos

Experienced Quality Assurance professional with expertise in the Pharmaceutical Industry.

Brazil

What I'm looking for

I am looking for a job that offers a challenging and dynamic work environment, where I can utilize my expertise in Quality Assurance to contribute to the success of the company. I value a company culture that promotes continuous learning and growth opportunities. I am particularly interested in roles that involve leading teams and coordinating quality management activities.

I am a highly skilled Quality Assurance professional with a strong background in the Pharmaceutical Industry. I hold a degree in Pharmacy from the Federal University of Goias and a Master's degree in Pharmaceutical Sciences from the same institution. Additionally, I am a certified Black Belt Lean Six Sigma from IPOG.

Throughout my career, I have gained extensive experience in Quality Assurance, specifically in Supplier Qualification, Internal Quality Audits, Supplier Audits, Risk Analysis, Quality Training, Product Quality Review, Document Control, and Data Integrity. I have also conducted health inspections and worked closely with Regulatory Affairs for Post Registration and Supplier Qualification matters.

Some of my notable achievements include the implementation of Supplier Qualification activities in accordance with RDC 658/22, participation in ISO 14001 Certification project, and the development and implementation of a paperless supplier qualification project. I am a natural leader and have successfully led teams and coordinated various management topics.

Experience

Work history, roles, and key accomplishments

GR

Quality Assurance Coordinator

Greenpharma

Responsible for handling and monitoring items related to Health Inspection, 02 CBPF inspections and 05 CTOs. Point of contact and support for inspection-related matters. Implementation of Periodic Product Review procedures, routines and evaluations.

GR

Senior Quality Assurance Analyst

Greenpharma

Participation of the technical team of the SUVISA/ANVISA Health Inspection, as responsible for Quality Assurance. Conducting the Data Integrity Project in the company.

FB

Quality Assurance Coordinator

Fresenius Kabi Brasil

Management of the Company's suppliers and Global Report on activities carried out locally. GAP assessment of international legislation for export authorization purposes. Management of Substances Controlled by Ordinance 344/98. Control and renewal of the company's legal documentation. Review and approval of documents from the Equipment Validation and Qualification team. Preparation and control of Q

FB

Senior Quality Assurance Analyst

Fresenius Kabi Brasil

Execution of qualification activities for suppliers of Active Pharmaceutical Ingredients. Support in audits and inspections. GAP Assessment of Corporate Procedures. Support in the activities of Qualification of Excipient, Packaging Material, Services and Transport Suppliers.

FB

Quality Assurance Analyst

Fresenius Kabi Brasil

Execution of qualification activities for suppliers of Active Pharmaceutical Ingredients, Packaging Material, Services, Non- Productive Material and Transport Companies. On-site audits at Packaging Material suppliers. Investigation of supplier deviations. Support in audits and inspections.

HF

Junior Quality Assurance Analyst

Halex Istar Indústria Farmacêutica

Execution of qualification activities for suppliers of Raw Material, Packaging Material, Services and Transport Companies. On-site audits at Transport Companies. Investigation of supplier deviations. Documents control. Preparation, programming and execution of annual training on good manufacturing practices and integration of new employees.

SP

Validation assistant

Sun Pharma

Organization of the schedule, preparation of Product Quality Review reports and presentation of results to management. GAP Assessment of Corporate Procedures. Monitoring of process validation activities. Organization of documents in the archive.

Education

Degrees, certifications, and relevant coursework

Aline hasn't added their education

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Tech stack

Software and tools used professionally

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Aline Carlos de Oliveira - Quality Assurance Coordinator - Greenpharma | Himalayas