Bénédicte Lagarrigue Email & Phone Number

Lyon, Fr

Lyon, Auvergne-Rhône-Alpes, France

Gothenburg, Vastra Gotaland County, Sweden

- QA for an ATMP new investment project, review and approval of criticality assessments, validation plans, protocols (pre and post execution SAT, IQ, OQ, PQ), validation reports, incident reports and deviations- Involved in risk assessment process including meeting management, response review and expert advise

Messimy, Auvergne-Rhône-Alpes, France

- Led and managed a team of 11 people on different Quality processes: Internal Audits, Training, Supplier Quality, Change Control, Product Quality Review and Pharmaceutical Documentation - Organized the activity within the team and prioritized in relation to the company's new projects - Implemented and maintained a quality system that ensures compliance with relevant regulations and standards- Provided guidance and support to other departments to ensure that quality is embedded in all processes- Successful harmonized practices and work methodology in the management of different types of suppliers - Updated the Product Quality Reviews in order to increase efficiency while meeting GMP requirements

Messimy, Auvergne-Rhône-Alpes, France

- Controlled promotional documents for medicines marketed in France - Provided regulatory support for the Marketing and Communication teams and the subsidiaries- Ensured the regulatory compliance of the corporate communication- Validated packaging of items for products marketed in the various countries of the Group - Simplified the validation process for promotional materials by setting up a delegation of the Head Pharmacist

Messimy, Auvergne-Rhône-Alpes, France

- Conducted internal audits of manufacturing areas, equipment, and facilities to ensure compliance with GMP and Standard Operating Procedures (SOPs)- Trained and educated employees on quality assurance processes and procedures- Reviewed and approved manufacturing and packaging documents - Investigated and documented any product quality issues, identified root causes and recommended CAPA- Reviewed batch files, certificated and released batches- Planned exchange meetings to ensure timely processing of anomalies and associated CAPA- Implemented a checklist for the harmonization of batch record review

Genay, Auvergne-Rhône-Alpes, France

- Validated cleaning, packaging and sterilization processes for medical devices- Qualified equipment and utilities- Participated in the project to move to a new production site: creation of plans for the controlled atmosphere areas, installation of equipment, definition of product/personnel flows and implementation of procedures

Lyon, Auvergne-Rhône-Alpes, France

- Managed a production team of 4 technicians in order to meet production goals to support internal and external customer expectations for quality, delivery and cost- Initiated and led the optimization of the reliability of aseptic process through daily operations- Implemented preventive maintenance and periodic requalification of equipment

Lyon, Auvergne-Rhône-Alpes, France

- Monitored and processed microbiological controls on the products and the environment- Validated medical device sterilization processes and release of sterilization batches- Conducted external audits of sterilization subcontractors and control laboratories- Settled up a hygiene training course for staff working in cleanroom- Internalized the microbiological control of water in accordance with the European Pharmacopoeia standard

Master'S Degree, Microbiology And Quality Control

Marketing/Marketing Management, General

Doctor Of Pharmacy - Pharmd