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Luis
Senior Quality Assurance Auditor
Contato
Competências
Experiencia demostrada en Chromatography.
Experiencia demostrada en Upstream Processing.
Experiencia demostrada en Autoclave and sterilization.
Experiencia demostrada en Spectrophotometry.
Experiencia demostrada en Downstream Processing.
Formação acadêmica
Resumo
Senior Quality Assurance Auditor buscando nuevas oportunidades
Experiência
Sr. Quality Engineer
Provide guidance to manufacturing personnel related to data integrity practices and quality systems.. Lead end to end investigations for deviations and quality events.
Supplier Quality Engineer II
Review of all new supplier requests for impact on quality system and required control including supplier questionnaires, quality agreements and supplier site evaluations.. Facilitating and performing component/material qualification.. Assists in the development of PFMEA, change control evaluations, etc.. Trained and qualified on the corresponding procedures before starting any test.. Building relationships with suppliers ensures that purchased components meet specifications.. Utilize analytical skill sets to implement root-cause analysis and provide recommendations for corrective actions.
Sr. Validation Specialist
Perform quality control laboratory equipment decommissioning and its removal ensuring all equipment and associated systems are taken out of service meeting with applicable regulations, and procedures related. This process includes filling out the forms and documentation requirements follow by its change control approval workflow using True Vault system.. Complete plan and report generation process gathering its necessary test case requirements as attachments including out of service, final calibration, logbooks, record transfer forms and additional supporting evidence.. Obtaining, completing, and complying with the Equipment Decommissioning and Removal Sign-off Checklist.. Working with different departments to get the representative signatures from relevant parties (such as calibration, Business Program Management, Facilities Engineering, and the EHS Department).. Apply Risk Assessment tools and participate in FMEAs as required.. Conducts testing following applicable procedures, cGMP’s, corporate and any other applicable regulation.. Actively participate in daily meetings to show the status of decommissioning progress activities for the project.
Compliance Document Specialist Consultant
Works with Manufacturing to deliver timely batch record review across all shifts.. Reviews and Approval Logbooks assigned to Microbiology, Bioassays, Chemistry, and raw materials documentation.. Develops appropriate disposition metrics, works with manufacturing personnel to achieve said targets. Generates and reports on metrics on agreed frequency.. Creates training materials for subject matter input.. Track and manage periodic review of approved manufacturing procedures.. Develop strategies and documents for cleaning and process validation of API equipment and products in compliance with site SOPs and regulatory guidance.. Provides data to support management evaluation of performance trends.. Owns quality records (change control, CAPA’s, deviation assessments) and delivers to establish timelines.. Autonomously leads and manages projects to implement continuous improvement opportunities.. Lead and/or support root cause investigations related to performance trends and formal deviations.. Develop, implement, and assess solutions for complex problems.. Provide guidance to laboratory activities including the review of quality documentation, such as, product specifications, chemical methods, chemical (analytical) report forms, SOPs, and quality and compliance guidelines.. Apply quality standards and regulatory requirements to different operational scenarios.. Reviews document for accuracy and completeness.. Defends the validation programs and strategies to customers and regulatory auditors.. Performs weekly quality reviews of Veeva database by assuring new documents have been entered using appropriate protocols.. Compliance with cGMP’s and applicable specifications, procedures, among others.. Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.. Performs other duties as assigned.
Quality Engineer II
Apply technical and analytical skills including sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.. Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.. Lead corrective and preventive action (CAPA) projects using root cause analysis as well as identifying and implementing robust solutions.. Review and approve product, process, software qualification and validation and other change control related documentation.. Builds productive and effective relationship with internal and external customers, such as Manufacturing, Quality Assurance, Planning, and others.. Establish with requirements of ISO 13485 and company Environmental, Health and Safety standards and follow procedures and instructions related to these standards.. Plans, organize and prioritize own daily work routine to meet an established schedule.. Support the development of new products and the transfer to production through cross-functional team collaboration, understanding technical requirements, supporting qualifications, and ensuring adherence to the quality system and regulatory requirements.. Perform product release activities and recommend batch disposition.. Provide direct support to on-going manufacturing of products by identifying and implementing effective process control systems that meet or exceed internal and external requirements.. Performs direct support working in the operational/performance qualification for injection molding.
SR. Quality Engineer
Responsible to evaluate and approve validation documents regarding to sensors product line used for the diabetes treatment such as PFMEA, DFMEA, TMV, IQ, OQ, IQR, TFV, QBE, EHS and PM revision. Manage documents through SAP Program system, Agile PLM & MAP and TrackWise and Global LIMS. Write special engineering requests to get units of manufacture for further testing. Participate in a daily meeting to update task and validation responsibilities to the project.. Key person in the new product implementation project for validation process evaluation and approves plans and reports, responsible for the evaluation of documents such as PPM, FAT, CSV process etc.. Support and prepares with team members a validation process plan for a weekly Quality Board presentation.. Working in a daily manufacturing line to resolve or report any unexpected situation related to quality system.. Maintains environmental records and manages environmental sampling also reports monitoring results.. Knowledge in lean manufacturing, 5s Methodology, 5why’s and root cause analysis.. Participate in a daily meeting to represent quality for each process and equipment assigned such as evaluation of new equipment, adding a manufacturing process, qualification strategies and evaluation of any impact on the product.. Supporting production floor activities in manufacturing environment.. Review and approve batch production records and disposition.. Knowledge of Good Manufacturing Practices, Good Documentation Practices and Good Laboratory Practices, MP, FDA EU regulation and ability to interpret them.. Perform meetings to be align with manufacturing in the new procedures or guidelines changes.. Collaborate and approve Special engineering builds in the pre-DVT evaluation.. Evaluate and approve Nonconformance product and notifications in SAP program.. Supports or initiates investigations of non-conformances (such as NCR, CAPA, Audit Observations), Out of specification (OOS) and initiates and maintains interplant communications of quality issues.. Collaborate and discuss new ideas with team members to perform and complete test cases in the protocols.. Analyzing data detecting deviations and interpreting results.. Review and approve documentation of experimentation, validation, new product implementation, Reports, Process and Cleaning Validation, Computer Validation Lifecycle documents, Risk Assessment for Qualification purposes, Installation Qualification, Operation Qualification, Technical Projects, Applications Change Controls.. Support and actively participate in regulatory inspections and internal audits.. Proactively participates in company initiatives toward continuous improvement (New Products Introduction, GMP Improvement Programs, Kaizen events, GENBA walks).. Participates in the investigation of OOS and atypical events and/or quality issues placing particular attention to root cause analysis.. Analyzing control monitoring humidity and temperature parameters as part of the facility validation room using data logger readings.
Quality Engineer
Review and approve product documentation monitoring, testing and thorough inspection to assure compliance with standards and FDA Regulations. Approve and evaluate required qualification testing such as SP, TMV, IQ, OQ, IQR, TFV, PM, PFMEA, SAP notifications, Improve manufacturing procedure as WIP, SOP. Daily communication with process SME from MMO site to assure the quality and proper operation during product transfer to PR site. Approved Change Orders (CO) related to transfer product implementation activities.. Experience on pull test implementation projects such as MFG procedures improvement, PM procedure on Rough Draft and TMV. Coordinate with several departments to discuss approved changes with personnel impacted.. Participate during day-to-day operational and project status meeting. Quality engineers run tests and duplicate real-world conditions. Evaluate applicable testing along manufacturing engineers for tooling, manufacturing equipment and fixtures. Assure implementation activities related to the product transfer meets FDA regulations, politics and establish procedures.. Review instrumentation preventative maintenance as deemed required to maintain the operational status of instrumentation.. Experience using tools such as micrometers, calipers, gauges, and volt meters, as well as electronic inspection equipment.. Ensure compliance with change management processes.. Review and approve EHS assessments, policies, and procedures to ensure compliance with applicable local, federal regulations and company directives.. Working with the production team to implement new testing criteria or assembly methods developed.. Submit and conduct changes in manufacturing process or instructions as part of the change control request process.