Sandrine Hareng

I am embarking on an entrepreneurial adventure by offering my QHSE support services to companies, as well as advice, audits, and training. Business sectors: Agri-food, Pharmaceutical, Cosmetics, Biotechnology, Medical Devices, Mass distribution. Geographic area: Puy-de-Dôme and Allier preferably. Short or long-term assignments, full-time or part-time, shared-time,

Process and QSE Engineer: Project to bring an existing building into compliance for the production of Medical Devices

- Develop PFDs, UFDs, and PIDs

- Write process and utility balance sheets

- Size industrial equipment

- Develop layout plans

- Write basic functional analyses

- Participate in writing technical documents: data sheets, technical specifications of needs,

- Write project follow-up meeting minutes

- Compliance analysis with ISO 13485 standard

Industrial Risks Engineer

- Write ICPE regulatory files (Information Notice, Hazard Study)

- Regulatory positioning studies for the compliance of existing installations or the design of new projects

- Conduct ICPE classification and regulatory compliance audits

- Participate in risk and safety analyses in working groups (HAZOP and HAZID),

QUALITY:

- Management of the Quality and Food Safety Management System

- Facilitation and Review of HACCP

- Staff Training: GMP, Food defense, Food fraud, Food Safety Culture

- Monitoring and tracking of quality indicators

- Writing and revision of quality, production, and quality control procedures

- Writing, revision, and validation of production files, specification sheets, operating procedures

- Verification and validation of batch records

- Management of complaints, non-conformities, deviations, change control

- Monitoring of ANSM and DGCCRF inspections, audits (clients, certifications, kosher, and halal)

- Conducting internal and external audits

- Implementation and monitoring of action plans

- Coordination with various departments on new developments, process changes, equipment, action plans

- Writing and defining process validation files (projects, improvement of existing processes), qualification of production equipment

- Selection, approval, and evaluation of suppliers and subcontractors

- Updating raw material documentation in collaboration with the purchasing team: food contact, allergens, absence of animal origin certificates

- Implementation and maintenance of ISO 22000 and FSSC 22000 certifications at the 2 production sites certified in July 2018 and January 2022

HSE

- Training and awareness of teams on the approach and compliance with HSE procedures

- Evaluation and update of the DUERP

- Management of PPE (selection, procurement, distribution, and monitoring)

- Management of hazardous and non-hazardous waste

- Management of staff authorizations and refresher courses (First Aid, Forklift License, Electrical, Fire safety...)

MANAGEMENT

- Supervision of a QHSE technician

- Interim supervision of a team of 5-6 production technicians for 6 months

PRODUCTION

- Planning of production operations (fermentation, concentration, lyophilization, mixing)

- Management of internal and client stocks,