MAGALI COLACI
BARCELONA
Summary
Biochemist with extensive experience in the pharmaceutical industry, specializing in various pharmaceutical forms. Results-oriented production supervisor with a strong background in team leadership, task delegation, and compliance with regulatory standards and Good Manufacturing Practices (GMP). Specialist in various quality-related matters, including leading audits, investigations, handling complaints, and conducting interdisciplinary meetings.
Overview
9
9
years of professional experience
Work History
Production Supervisor- Quality Specialist
Laboratorio Elea
Buenos Aires
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-
Buenos Aires
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
Buenos Aires
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 softwares Trackwise, InforEAM, and SIMATIC PCS7. Trained end users on its functionality.
Production Supervisor
Laboratorio Dr Gray SACI
Buenos Aires
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
Buenos Aires
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
- Training and mentoring
- Manufacturing
- Employee leadership
- Audit management
- Process Documentation
- Quality assurance expertise
- Standard Operating Procedures
- Communication
- Team work
- Problem-solving
Languages
Spanish
First Language
English
Upper Intermediate (B2)
B2
Italian
Elementary (A2)
A2
Timeline
Production Supervisor- 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 - Biochemistry
Universidad De Morón
Associate of Science - Pharmacy
Universidad De Morón
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