MAGALI COLACI
BARCELONA
Summary
Biochemist with extensive experience in the pharmaceutical industry, specializing in various pharmaceutical forms. Proven ability to lead large multidisciplinary teams, manage production plans, and ensure strict compliance with GMP standards. Skilled in process optimization, deviation management, and cross-departmental coordination to achieve efficiency and quality objectives in dynamic environments.
Overview
11
11
years of professional experience
Work History
Production Supervisor- Injectables
Laboratorio Reig Jofre
11.2024 - Current
- Supervised a team of over 15 employees in a sterile, injectable manufacturing plant, specializing in liquid and lyophilized products.
- Assigned tasks to employees based on planning and available resources to ensure efficient operations and adherence to schedules.
- Managed daily and weekly production plans, adapting priorities to meet operational goals.
- Monitored process parameters during batch manufacturing to ensure compliance with quality standards and operational efficiency.
- Coordinated production requirements with planning, maintenance, and validation teams to ensure seamless workflow
- Ensured that all employees comply with GMP regulations.
- Delivered technical and GMP training for new employees and ongoing training for the team
- Technical review of production batch record
Production Technician- Quality Specialist
Laboratorio Elea
08.2022 - 03.2024
- Supervised a team of 40+ employees, ensuring tasks were completed efficiently and accurately.
- Coordinated resources in a solid manufacturing process: dry and wet granulation, mixing, drying, encapsulation, compression, drilling, and coating.
- Coordinated production requirements with material handling and staffing functions, while establishing priorities and sequences for manufacturing processes.
- Communicated effectively with other departments, like planning, validation, R&D, manufacturing, to ensure smooth workflow from start to finish.
- Read and interpreted work order specifications and information to plan, schedule and carry out jobs effectively.
- Used SAP software
- Ensured safety regulations were followed by all personnel in the production area.
- Created detailed reports outlining progress on various projects.
- Participated in external audits and regulatory inspections, providing necessary documentation and support.
- Led with quality compliance internal audits to identify areas for improvement and ensure adherence to quality management systems, and prepared reports to communicate results of quality inspection activities to management.
- Analyzed customer complaints and deviations, identified root causes, and implemented corrective action plans.
- Reorganized and revised standard operating procedures to streamline processes and improve communication and collaboration.
- Collaborated with the product development team to establish manufacturing criteria for new products.
- Determined training needs of staff and organized training interventions to achieve quality standards.
- Trained staff on production processes and procedures.
Production Supervisor
Catalent Pharma Solutions-
09.2019 - 08.2022
- Oversaw a diverse team of 50+ employees, ensuring timely and accurate completion of production tasks.
- Directed production activities in the gelatin, encapsulation, inspection, and packaging areas by establishing priorities and sequences to optimize manufacturing processes.
- Coordinated manufacturing department activities with validation, logistics, QC, QA, and technology areas to achieve company objectives.
- Analyzed data from monthly productivity reports to identify trends and potential issues with current processes.
- Participated in the recruitment of employees for new manufacturing positions and conducted interviews.
- Monitored adherence to GMP operating procedures and cleanliness mandates, achieving compliance with regulatory standards.
- Reorganized standard operating procedures to streamline operations and enhance team communication.
- Provided constructive feedback and development plans to team members to enhance their job performance.
- Supported external audits and regulatory inspections by providing thorough documentation and assistance.
- Drafted investigation reports on quality deviations and customer complaints using Root Cause Analysis, and collaborated with the quality team to establish corrective and preventive actions.
- Member of the Technical Training team for operators in the company's regular courses.
Sr QA Analyst Release /Sr Investigation Specialist
Catalent Pharma Solutions
12.2017 - 08.2019
- Developed and maintained quality assurance protocols, processes and procedures.
- Interpreted test results, compared to specifications and control limits and recommended data for release.
- Reviewed and approved quality-related documents, ensuring compliance with internal and external standards.
- Managed quality deviations and non-conformities, including out-of-specification results and out-of-trend results, coordinating investigations and ensuring effective resolutions.
- Utilized root cause analysis techniques to identify and rectify quality-related problems.
- Coordinated with cross-functional teams to address quality issues and implement corrective actions.
- Facilitated training sessions for staff on quality assurance procedures and policies.
- Prepared and presented detailed reports on quality metrics, trends, and improvement initiatives to management.
- Participated in external audits and regulatory inspections, providing necessary documentation and support.
- Coordinated with cross-functional teams to address quality issues and implement corrective actions.
- Managed the software's Trackwise, InforEAM, and SIMATIC PCS7. Trained end users on its functionality.
Production Supervisor
Laboratorio Dr Gray SACI
04.2017 - 12.2017
- Coordinated a team of 15+ employees, ensuring tasks were completed efficiently and accurately.
- Supervised the manufacturing, filling, reviewing, and secondary packaging processes of sterile injectable products.
- Supported safe and clean work environment by educating and directing personnel on use of control points, equipment and resources.
- Planned production operations while establishing priorities and sequences for manufacturing processes.
- Conducted performance reviews to identify and rectify areas for skill improvement.
- Reviewed and modified job specifications to adapt and align them with practices, procedures, and regulatory specifications.
- Reviewed and submitted production documentation for quality assurance, including batchs record, procedures, deviations and protocols.
- Analyzed data and prepared monthly production reports to identify trends and areas for improvement.
Operational Quality Assurance Analyst
Laboratorio Dr Gray SACI
04.2015 - 04.2017
- Reviewed and approved quality documentation in accordance with quality standards and regulations, including batch records, change controls, deviations, maintenance work orders and procedures.
- Analyzed test data from laboratory tests to determine if product meets established standards of quality.
- Verified that products met the required safety standards before being released.
- Developed corrective and preventive action plans to resolve non-compliance issues.
- Conducted trend analysis through annual product reviews to identify process improvements and prevent quality deviations.
- Conducted process checks at the specified frequency on the production lines to verify quality standards and ensure compliance with specifications.
- Monitored production lines to ensure compliance with good manufacturing practices.
- Selected samples for use as test models.
- Audited supplier performance against predetermined criteria related to product quality.
Education
Associate of Science - Biochemistry
Universidad De Morón
Buenos Aires, Argentina04-2018
Associate of Science - Pharmacy
Universidad De Morón
Buenos Aires ArgentinaSkills
- GMP
- SAP
- Manufacturing Processes
- Documentation & SOPs
- Incident and deviation investigation
- Audits & Inspections
- Training and mentoring
- Team leadership
- Decision-making
- Planning
Languages
English
Upper Intermediate (B2)
B2
Italian
Elementary (A2)
A2
Spanish
Bilingual or Proficient (C2)
Timeline
Production Supervisor- Injectables
Laboratorio Reig Jofre
11.2024 - Current
Production Technician- Quality Specialist
Laboratorio Elea
08.2022 - 03.2024
Production Supervisor
Catalent Pharma Solutions-
09.2019 - 08.2022
Sr QA Analyst Release /Sr Investigation Specialist
Catalent Pharma Solutions
12.2017 - 08.2019
Production Supervisor
Laboratorio Dr Gray SACI
04.2017 - 12.2017
Operational Quality Assurance Analyst
Laboratorio Dr Gray SACI
04.2015 - 04.2017
Associate of Science - Pharmacy
Universidad De Morón
Associate of Science - Biochemistry
Universidad De Morón