Luis Sandoval Herrera Email & Phone Number

San Pablo, Ca, Us

Redwood City, California, United States

• Responsible for providing QA oversight and support for batch disposition, quality record ownership, and management of QA activities.• Represent QA on cross-functional teams and serve as a resource for quality and compliance questions, issues, and planning across the development organization, including providing guidance based on current global regulations, industry standards, and best practices.• Collaborate with internal and external stakeholders on deviation investigations, CAPA plans, change controls, shelf-life extensions, and revisions to documentation.• Lead efforts for QA oversight of the manufacture and disposition of pre-clinical, clinical, and commercial product materials, DS, DP, and FP at CMOs in partnership with CMC, Supply Chain, Analytical Development, and other functions.• Execution of Quality Systems as Quality SME for Deviations, CAPAs, Change Controls, and other Quality processes.• Lead and actively participate in continuous improvement initiatives and projects, ensuring a focus on increasing both efficiency and quality output from all processes used by cross-functional partners.• Establish quality metrics at the CMOs that predict the performance and health of the quality systems and processes and effectively communicate compliance-related metrics, risks, and compliance challenges to senior management.• In collaboration with the Analytical Development function, provide quality oversight for GMP activities including, approval of Method Validation, Specifications, Release testing, and Stability for Drug Substance and Drug Products.• Review and approval of CMO documentation (e.g., specification documents, master batch records, label proofs, etc.) as well as review executed batch records, applicable test data (in-process and release), and performing product dispositions.• Support quality review of regulatory documents (IND/IMPD).• Participate in inspection readiness efforts.

San Carlos, California, United States

The role is responsible for the primary, hands on, day-to-day, cGMP oversight role for all site related GMP ac-tivities. They interact directly with site staff, who are performing the daily operational functions in support of their effort to produce quality products. The Senior role directly supports the GMP Facilitator role and also re-quires functional involvement in peripheral activities that support the Quality, PU, Engineering, or Facilities departments.Responsible for ensuring compliance with Federal (FDA, EPA, OSHA), State and local regulations. Ensure adherence to all company policies and procedures relating to current Good Manufacturing Practices, Standard Operating Procedures and Health, Safety and Environmental Protection.• Responsible for commercial product, raw materials and components release, disposition and material handling as part of the support supply chain planning (NOSSCE)• Provides oversight to operations on the shop floor, supporting operators and support staff as needed to identify and address product quality and compliance issues as they arise.• Responsible for driving product quality improvements by coordinating investigations and corrective actions with all operating units, QA, Site Services, and suppliers. Evaluation and decision of deviation reports in AQWA (TrackWise)• Support Quality Assurance and Compliance with internal audit coordination, response, and follow-up activities.• Participate in or lead internal/external audits, as needed.• Compilation of data and information for contribution to Risk Assessments and Reports (e.g. APR/PQRs).• Authoring and revision of SOPs in the department’s area of responsibility, as well as other departments as necessary.• Participation in and conducting of trainings.Follow all hazardous materials and hazardous waste management regulations and guidelines.• Ensure compliance with GMP/HSE regulations, Novartis policies, procedures and standards as appropriate for the role.

San Carlos, California

 Hands-on day to day, GMP facilitator for all site-related GMP activities Release commercial product, raw materials and components, material handling and support of Supply Chain Planning Business Process Owner (BPO) of NOSSCE for Master Schedule Production Quality (MSPQ) and On-Time-Batch Approval (OTBA) Coordinate investigations and corrective actions with all operating units, QA, Site Services, and suppliers. Evaluation and decision-making for deviation reports in AQWA (TrackWise) Support implementation of CAPAs, SOP revisions, Quality improvement initiatives, Operational Excellence projects Adhere to internal/external Guidelines, Specifications and Regulatory requirements while reviewing batch documentation. Ensure all GMP's, SOP's and protocols are followed. Positively interact with internal associates to quickly and effectively resolve issues. Address deficiencies and ensure completion of follow-up actions, to batch review issues according to GMP standards Conduct Internal Audits of processes and facilities

San Carlos

Review batch documentation for accuracy and completeness according GMPs to ensure timely release and also help to final disposition.Support implementation of CAPAs, SOP revision, Approved Deviation using trackwise.