Hidde Osinga Email & Phone Number

Leiden, South Holland, Netherlands

Positioned at Janssen Vaccines in LeidenPosition: Project Qualification leadPositioned via Bilfinger Tebodin BV.Project Qualification engineer responsible for the qualification of new Biotech start-up equipment for production of RNA-based vaccins. Setting up qualification program and defining project deliverables according site risk assessments and procedures.Job contents- Responsible for the qualification of new Biotech equipment- Setting up qualification plan- Writing, reviewing and approving URS documents- Organizing risk assessments for qualification- Writing risk assessment reports- Writing qualification (IQ, OQ) protocols and reports- Executing qualifications- Reporting defects- Coordination, scheduling and supervising of qualification activities- Supporting project leads in setting up project documents

Breda, North Brabant, Netherlands

Positioned at CEBAN BVPosition: Qualification and validation consultantSupporting validation department in improving the Cleaning Validation strategy and making the Cleaning Validation Operational. Training an CEBAN employee in cleaning validation. CEBAN is a Compounding Pharmacy manufacturing three hundred different products for oral and dermal use (ointments, creams, solutions, tablets, capsules) Job contents- Responsible for improving Cleaning Validation Strategy.- Setting up Cleaning Validation Schedule / Plan - Writing Cleaning Validation Policies, Procedures and related documents- Writing Cleaning Validation Protocols- Setting up sampling and recovery studies for Cleaning Validation - Executing Cleaning Validation Protocols and reporting- Training CEBAN employee in all aspects of Cleaning Validation- Improving Cleaning Procedures for Equipment- Training and supervising Junior Yxion consultant in Equipment qualification

Haarlem, North Holland, Netherlands

Positioned at MSD Global Engineering Solutions (GES), site MSD HaarlemPosition: Commissioning & qualification (C&Q) lead in a project of a new QC Analytical laboratory (CAPA project of 25 mil. euro) containing PW system, fume hoods, biosafety cabinet, freezers and chemical waste tank system.Job contents- Responsible for the C&Q part of the project until handover- Writing commissioning and qualification policy, strategy and assessment plans- Writing Project Validation Master Plan- Reviewing Design Built Contractor (DBC) commissioning protocols and reports- Writing qualification (IQ, OQ) protocols and reports- Executing qualifications and commissioning tests (temperature mapping studies of QC laboratory areas)- Reporting defects- Writing, executing and reporting safety assessments with DBC and safety experts.- Reviewing and approving project turn over documents (technical documentation, test documents, drawings, certificates etc.)- Coordination, scheduling and supervising of commissioning and qualification activities

Haarlem, North Holland, Netherlands

Positioned at MSD Global Engineering Solutions (GES), site MSD HaarlemPosition: Commissioning & qualification (C&Q) lead in a project of a new warehouse for cold storage of pharmaceutical products (CAPA project of 35 mil. euro)Job contents- Responsible for the C&Q part of the project until handover- Writing commissioning and qualification policy, strategy and assessment plans- Writing Project Validation Master Plan- Reviewing Design Built Contractor (DBC) commissioning protocols and reports- Writing qualification (IQ, OQ) protocols and reports- Executing qualifications and commissioning tests (temperature mapping studies of cold storage warehouse areas)- Reporting defects- Writing, executing and reporting safety assessments with DBC and safety experts.- Reviewing and approving project turn over documents (technical documentation, test documents, drawings, certificates etc.)- Coordination, scheduling and supervising of commissioning and qualification activities

Oss, North Brabant, Netherlands

Positioned at MSD Biotech USP, site MSD Oss De GeerPosition: Asset Specialist Upstream Biotech Production of pharmaceutical API’s by cell culture and GGO’s in biomass fermenters.Job contents- Qualification of production equipment, utilities and clean rooms- Initiating, implementing and reporting of Change Control- Writing Periodic Reviews of equipment, utilities and clean rooms - Coordination of activities of third parties- Initiating CAPA’s.

Oss, North Brabant, Netherlands

Positioned at MSD Global Engineering Solutions (GES), site MSD Oss - De GeerPosition: Commissioning & qualification (C&Q) engineer in a project of a new warehouse containing ambient, cold and freeze storage areas for storage of pharmaceutical raw materials and cleanrooms for weighing and dispensing of pharmaceutical raw materials Job contents- Writing commissioning and qualification protocols, policy documents (for example C&Q Execution plan, project VMP)- Executing commissioning and qualifications tests- Writing commissioning and qualification reports- Reporting of punches and defects- Writing, executing and reporting safety assessments- Coordination of C&Q activities of contractors (third parties)- Executing of Factory Acceptance Tests (FAT) at suppliers

Weesp, North Holland, Netherlands

- Reviewing and reporting qualifications and validations of equipment, clean rooms and proccesses- Writing and reporting Validation Master Plan- Contribute to improvement of qualification and validation processes.- Contribute to improving of manufacturing processes- Contribute to the availability of status reports of calibration, qualification and validation of equipment, clean rooms and processes- Reporting of deviations and contribute to writing of CAPA's

Oud-Beijerland, South Holland, Netherlands

- Validation management- IQ, OQ, PQ qualification- Calibration magement- Cleaning validation- Process validation- Asset management- Change Control- Validation Master Plan- Project Management- Risk assessments (SIA, CIA, FMEA)

Rotterdam Area, Netherlands

- HACCP management system setup- Environment and safety management- Change Control management- Complaint management- Internal and external audits- Project management

Rotterdam

- IQ, OQ and OQ qualification- Calibration- Cleaning validation- Process validation- Validation Management- Change Control management- Complaint management- Internal and external audits- Project management

Rotterdam Area, Netherlands

QA Officer at Department of Immunology- Setup of a qualitysystem for laboratory acc. CCKL guidelines- Setup of quality meetings of quality engineers of medical laboratories

Bachelor'S Degree, Clinical Chemistry Laboratory, Hbo

Activities and Societies: Clinical Chemistry for Laboratory

Post-Hbo, Quality Management, Quality Engineer

Activities and Societies: Quality Magament Statisics Financial management Quality engineering Auditing