Anely Castro
Pearland,TX
Summary
Talented and dynamic leader with extensive quality assurance experience in the biotechnology and pharmaceutical industry. Excellent reputation for teamwork, innovative problem solving, and performance improvement. Strong history in audits, regulatory compliance, and employee development.
Overview
26
26
years of professional experience
Work History
Regional Quality Manager/Quality Systems Manager/Quality Assurance Supervisor
Grifols
06.2008 - 07.2023
- Ability to conduct GMP compliance audits independently
- Development and generation of audit reports and follow-ups
- Site product troubleshooting
- Regularly perform review of site audit responses and provided feedback to include investigations, evaluating root causes, and comparing corrective and preventive actions from prior on-site audits to ensure actions were effective
- Evaluate metrics to report on the performance of the quality system to site and corporate management
- Execution of Quality Systems Management (CAPA, complaints), root cause analysis, tracking and trending
- Assist in regulatory communications, participate in FDA, and foreign regulatory agencies site audits
- Manage and participate in adjunct projects, contributing knowledge of FDA, EU, and organizational audit expectation to improve site performance
- Knowledge of 21 CFR 210-211 and ISO 9001: 2015
- Familiar with 21 CFR 820 and ISO 13485
- High level perspective on managing key performance indicators
- Evaluated Key Performance Indicator scores per site and discussed process improvement initiatives with leadership teams
- Directly impacted performance excellence across varying departmental expectations and environments through development, training, coaching, and mentoring of teams
- Provide performance-based feedback to direct reports, including completion of annual performance reviews
- Coordinated with the client, and senior staff to identify and implement opportunities for continuous improvement reducing costs and increasing and/or improving efficiency, while maintaining quality
- Regularly collaborated with operations management to initiate or review investigations, determine root cause, and align corrective and preventive actions, as well as monitor for reduction of error and/or downward trend
- Measure progress of Key Performance Indicators toward key business goals
- Support implementation of effective and efficient processes that fulfill regulatory requirements and expectations in a sustainable way as the system administrator of the quality management document support system
- Leads plant quality teams by facilitating alignment across the business unit through a cadence of standard work
- Manage a team of quality professionals, ensuring they meet annual quality objectives and receive necessary support and development.
Staff Process Engineer/Technologist Process Specialist IV/Lead Investigator
Pfizer
06.1997 - 06.2008
- Management of Change Control and Change Requests for implementation of projects.
Education
Bachelor of Science: Biology -
InterAmerican University – Puerto Rico
Skills
- Auditing Expert
- Project Management
- Regulatory Compliance
- Team Building and Leadership
- Staff Training and Development
- Performance Improvement
- CAPA Development and Management
Timeline
Regional Quality Manager/Quality Systems Manager/Quality Assurance Supervisor
Grifols
06.2008 - 07.2023
Staff Process Engineer/Technologist Process Specialist IV/Lead Investigator
Pfizer
06.1997 - 06.2008
Bachelor of Science: Biology -
InterAmerican University – Puerto Rico
References
References – upon request
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