Luis Antonio Vega Bautista

• Project coordinator to assess the feasibility of change and continuous improvement in processes and products of the line with the purpose of improving efficiency, reducing waste, and times, as well, mitigating potential risks to product quality through methodologies such as Six Sigma, Quality by Design, and Design of Experiments. Acomplishments: Reduction of defective generated in the semi-finished product process by 70%, generating an increase in OEE of 20% in the packing lines.
• Asses product formulation
• procurement feasibility of new providers
• Technology transfer in situ of solid dosage process such as granulation, tablets, capsule,coating and packing)
• Completed paperwork, recognizing discrepancies and promptly addressing for resolution.
• Managed team meetings and discussed project's goals and objectives.
• Observed progress of each project, examined risks and coordinated contingency plans.
• Gained extensive knowledge in data entry, analysis and reporting.
• Worked flexible hours across night, weekend, and holiday shifts.
• Resolved problems, improved operations and provided exceptional service.
• Identified issues, analyzed information and provided solutions to problems.
• Participated in team projects, demonstrating an ability to work collaboratively and effectively.
• Used critical thinking to break down problems, evaluate solutions and make decisions.
• Acted as a team leader in group projects, delegating tasks and providing feedback.
• Strengthened communication skills through regular interactions with others.
• Applied effective time management techniques to meet tight deadlines.
• Delivered services to customer locations within specific timeframes.
• Exercised leadership capabilities by successfully motivating and inspiring others.

Execute and Planing of the the master validation plan using the following tools:

Problem analysis and root cause investigation.

Management of deviations and risk analysis and management tools.

Implementation of CAPA (Corrective and Preventive Actions).

Good documentation practices.

Statistical analysis (Statistical Process Control Cpk, Cp, etc.).

Performance qualification of pharmaceutical processes (tabletting, encapsulation, etc.).

Qualification of support processes (cleaning, sanitization, aseptic processing, etc.).

Simulated fillings of ampoules, syringes, and vials.

• Performed system analysis, documentation, testing, implementation, and user support for platform transitions.
• Validated results and performed quality assurance to assess accuracy of data.
• Assessed data modeling and statistics to integrate high-level business processes with data rules.
• Conducted workplace compliance training to reduce liability risks and operate effectively.
• Identified clear connections between policies and business results to eliminate or reduce confusion and help employees achieve goals.

Support in the development of the Quality Control Plan and PFMEA through the APIS IQ Software.

PFMEA audit (failure mode analysis) in the manufacture lines according to the corporate standard of the COC (Center of Competence).

PDCA Monitoring in the applied corrective actions based on the audited findings, 8D reports and customer complaints.

• Skilled at working independently and collaboratively in a team environment.

• Supervision of the packaging lines in order to ensure compliance with the finished product specifications (tequilas, vodkas, rum). Statistical process control to determine quality plans, sampling, and corrective actions.
• Developed monthly reports showing inspections and improvements.
• Established inspection equipment to meet quality control standards.
• Maintained QA programs.
• Monitored activities and supporting systems in bottled lines to check compliance with all institutional and regulatory requirements
• Supported audits and led teams to fully investigate quality control processes and root out deficiencies.