Jose Brenes Email & Phone Number

San Rafael, Ca, Us

Ensure the Information Management (IM) and Quality Assurance (QA) departments are compliant with all applicable regulations including FDA’s GLP, GCP and GMP/Part 11 and EU Annex 11 and industry guidelines like ISPE GAMP5 and PDA.Oversight of QC and Bioanalytical Labs Analytical Instruments, Automation, Enterprise, WWRD and SaaS computer system validation from a quality assurance perspective to ensure quality and compliance requirements are met.Oversight and support of the Quality Change Management process and activities associated with the implementation and validation of new GxP computer systems and/or changes to existing validated computer systems.

Responsible for QA review and approval of GxP computer system validation activities and documentation. Act as a QA lead for computer system validation projects, which includes Enterprise Applications, Lab Systems, Clinical Systems and Automation Systems. Specific duties include, but are not limited to:o Oversight and approval of validation-related documents, participating in risk assessments to determine which elements should be validated, and conducting validation impact assessments of proposed changes to computer systems.o Review and/or approval of computer systems Change Controls.o Conduct review and/or approval of periodic reviews of validated computer systems.o Review and approve computer system related GxP Deviations.o Support regulatory agency and corporate partner inspections and audits.o Oversee QA CSV Contractors as needed.o DEV-CAPA Metrics

Humacao, Pr, Pr

Project Management and CSV support for the IT and Execution Systems areas Janssen Supply Chain and Intarcia Therapeutics, Inc..Plan development and management, Meeting coordination, Task assignment, Metrics, Multiple site focal point, Problem solving, Resource Management, Computer Systems Validation Methodology Mentoring, Compliance and documentation/deliverables review.

Lawrence Township, Nj, Us

• Support to risk management tools / approaches toward the process development / characterization of EISAI automated inspection machine for prefilled syringes and vials, including but not limited to: o Strategy toward for the inspection of eject-units. o Machine / system challenges, setup and adjustment (as needed). o Defects monitoring (including but not limited to glass breakage).• Generation of related documentation, such as technical protocols, technical memos, technical reports, site procedures / forms (as needed).• Provide training to appropriate area personnel.• Define scope / requirements / requisites and provide support (development and execution) on validation activities (CSV, IQ/OQ/PQ), including but not limited to: o Equipment / System operation and performance o False acceptance rate (False-positive rejection rate) o False reject rate (False-negative refection rate) o Defect limits (allowable limit for rejects) o Eject rates o Process Yield limits

Raritan, New Jersey, Us

Directly responsible for the development and execution of qualification and process validation documentation related to the expansion of a solid dose production line. This included (but not limited) Factory Acceptance Test Protocols, Site Acceptance Test Protocols, Design Review/Qualification, Equipment IQQs, Computer Systems Validation, Process Risk Assessments, Investigations SOPs and Batch Records.

Franklin Lakes, New Jersey, Us

Responsible for the full validation of two new fully automated manufacturing lines which were the two major milestones of a product transfer from company’s headquarters to local site. This included development and execution of: Factory Acceptance Test Protocols, Site Acceptance Test Protocols, Equipment IQ/OQs, PLC/HMI Qualification, Performance Qualification, Standard Operating Procedures, Measurement System Analysis Protocols and Site Manufacturing Procedures (also known as Batch Records).

Vega Baja, Pr

Pennsauken, New Jersey, Us

• Manage validation projects at client sites.• Review and approve applicable validation deliverables.• Provide technical guidance, direction and expertise to resources based on a compliance approach.• Responsible for the resource planning and the QA of the work and services provided.• Prepare update and revise Project Plans including critical path, milestone and contingency.• Manage special assignments: Quality System Assessment, Validation Master Plan / Methodology Development, Improvement of time reporting structure/process.• Review, approve and assure compliance of all computer hardware/software validation documentation generated for Manufacturing Execution System (MES), Empower and LIMS Worldwide, with respect to client internal methodology and industry standards such as GAMP5 and 21CFR Part 11.• Assess, track and close Computer Change Controls (CCRs) generated for controlling changes to be performed on Laboratory, Manufacturing and Business computer systems.

Review, approve and assure compliance of all computer hardware/software validation documentation generated for Cordis Manufacturing Execution System (MES), PLC integration to manufacturing systems, Empower and LIMS Worldwide, with respect to Cordis internal methodology, SDLC (Software Development Life Cycle) and industry standards such as GAMP5 and 21CFR Part 11.Provide guidance, coaching and act as Subject Matter Expert (SME) for internal clients when implementing new computer systems or performing changes to existing critical (QSR) computer systems.Assess, track and close Computer Change Controls (CCRs) generated for controlling changes to be performed on Laboratory, Manufacturing and Business computer systems.

De Pere, Wi, Us

In charge of managing all validation projects at the designated client sites.• Supervise a staff of approximately 17 validation engineers and scientist.• Review and approve applicable validation documentation deliverables.• Perform interviews and performance appraisal of future prospects and existing resources.• Provide technical guidance to resources on validation projects.• Responsible for the resource planning.• Directly worked on the validation of several processes and systems such as HVACs, USP Water Systems, Facilities & Utilities, Manufacturing Lines, Microbiology and Analytical Laboratory Equipments, among others.

Managing the operations of the service department:• Administrative responsibilities included: service personnel scheduling, personnel evaluations, quality assurance, personnel training, all documentation revision/approval and technology updates.• Validation protocols development, execution and/or revision and approval (e.g. balances, autoclaves, UV’s, Karl Fishers, Walk-In Chambers, HPLC’s, GC’s, etc.) of almost every type of laboratory equipment at different pharmaceutical companies.• Project Management responsibilities included: project budgeting, resource planning, scheduling, proposal development, risk analysis.• Developed based on GMP and ISO 9002 (current ISO 17025) company Quality Manual, Standard Operating Procedures Manual and Work Instruction Manual.• Performed calibration, installations, repairs, preventive maintenance to critical equipment, scheduling the services, responsible for scheduling the calibration and maintenance of company’s standards.

Bachelor'S Degree, Electronic Technology

Bs, Electronic Technology