Brookhuis (Johan) Email & Phone Number

North Brabant, Netherlands

Boxmeer

Msd Oss

-Performing GMP audits in the clinical production area and analytical laboratories in the pharmaceutical industry including the Walk Through Audits, planning and reporting. -Monitor and pro-active management for audit follow up.-Witness the media fill process and attend root cause meetings in case of a media fail.-Maintain the site supplier and contractor database. Participate in the global audit group meetings and supply the needed pre audit information. -Site lead within RCQ (Research Commercialization Quality) for the SOP management system. -Authoring, review and approval of SOPs, work instructions and procedures ensuring that they are in line with international regulations (both regulatory and company regulations)-Ownership and editor of the Site Master File (SMF), annual update and release.-Review IT validation documentation regarding material management system.-Backup Quality approval for equipment, building and utility validation documentation.-Achievements: Successful regulatory inspections of the FDA, IGZ and third parties. Follow up the annual scheduled audit program without overdue and pro-active monitoring of the CAPA follow up. Successfully transfer for all SOPs from a retired system to the current used system and management of a large number of SOPs including metrics and SOP overdue administration. Successfully deliver the annual SMF update including cost reduction.

Oss

-Pro-active role regarding quality issues within the organization and recognition as Subject Matter Expert (SME) regarding GMP/Compliance and quality aspects.-Evaluation, assessment, review and approval of validation/qualification protocols and reports, involving equipment, utilities, adjustments to buildings and computer validation.-Providing a scientifically sound advice to the organization while preparing specifications/user requirements for manufacturing and lab equipment, utilities, adjustment to buildings and processes.-Evaluate and advise the organization of GMP impact during (new) investment projects.-Attendance of impact meetings and performing review and Quality approval in the change management process in relation to validation/qualification status.-Achievements: On time delivery of Quality related reviews and approvals. Maintain a pro-active approach to involve departments in the quality process.

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-Support the down stream production (DSP) process for the production of biochemicals, including column life time studies, protein removal, virus removal studies.-Set up and development of experiments to support the DSP process worked out by research analysts.-Be subject matter expert for the DSP process. Design and advice for equipment and process condition parameters.-Formulate optimization proposals for the DSP process.-Ownership and management of the process supporting documentation generated during the process development.-Achievements: Building a knowledgeable and costumer focused team. Keeping the DSP process in comply with the regulatory requirements. Optimized several process steps. Introduce innovative technics to improve the process

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Objective: Give lead to the DSP operators in several protein purification processes, subject matter expert for the DSP process, manage people, equipment, material and process planning. work according to product quality and safety regulations. maintain equipment, building and utility control.

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Give lead to the DSP operators in several protein purification processes

Oss

Part of the Biochemical Research team within Diosynth to optimize the production processes.