Paula Tatiana López
Assoc. Spclst, Clinical Data Mgmt @ MSD
About
Industrial Microbiologist with over 4 years of experience in supervising laboratory procedures, conducting physicochemical and microbiological analyses, and managing technical documentation. Skilled in implementing and monitoring Good Manufacturing Practices (GMP) to ensure product quality and safety. Strong knowledge of ISO 9001, ISO 14001, ISO 15378, GMP, and INVIMA regulations. Committed to continuous improvement, teamwork, and professional growth, I seek to contribute my expertise to dynamic and challenging environments that drive organizational success.
Colombia
Bogota
Pharmaceuticals
Biotechnology, Spanish, Continuous Improvement, Microsoft PowerPoint, Quality Assurance, Corrective and Preventive Action (CAPA), Laboratory Skills, Pharmaceutics, Good Manufacturing Practice (GMP), Quality Control, Quality System, Quality Management, Media Preparation, Sterilization, Water Analysis, English, French, Microsoft Excel, Design, Swimming
Experience

Head of Quality Control
Tocancipa, Cundinamarca, Colombia
Supervised GMP compliance, technical specifications, SOPs, and work instructions. Approved or rejected raw materials and finished products. Analyzed results from external laboratories and validated outsourced tests. Managed non-conformities, CAPAs, and performance indicators. Supported audits and supplier/client relations. Participated in the implementation of the GMP plan and the setup of the physicochemical laboratory.

Head of Quality Control
Bogotá, Capital District, Colombia
Approved raw materials, bulk, packaging, and finished products. Verified physicochemical, microbiological, and chromatographic tests (internal and external). Supervised GMP compliance. Managed technical documentation and product stability schedules. Supported process validations, supplier and INVIMA audits, and new product development.

Microbiology Analyst
Colombia
Performed microbiological and physicochemical analyses of raw materials, finished products, water, and packaging. Planned and executed microbiological sampling of environments, surfaces, equipment, and personnel. Conducted growth promotion tests and thin-layer chromatography. Recorded results, managed lab inventory, and generated quality certificates. Participated in process validations and stability studies. Implemented microbiological methods following USP guidelines.

Microbiology intern
Bogotá, Capital District, Colombia
Prepared and sterilized culture media. Collected and processed microbiological samples from surfaces, environments, equipment, and personnel. Managed inventory, supplier quotations, and raw material purchasing. Updated technical documents in accordance with USP, NTC, and BP. Analyzed purified and potable water using membrane filtration.
Paula Tatiana López's Contact Information
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