Antonia Williams Email and Phone Number

Developing and implementing robust, compliant quality systems processes for clients in the Cosmetic, Pharmaceutical (sterile and terminally sterile manufacturing), Biotech and Medical Device (including Software as a Medical Device) industries while compiling, measuring and analyzing, and recommending process improvements to ensure engrained Quality culture.

PQS Site Business Process Manager: Proactively develops and manage changes in controlled processes and procedures as the organization evolves, industry practices change and/or regulations change to assure high quality standards with applicable laws, regulations, guidelines and Roche policies.Discrepancy Management System Site Business Process Manager: Ensures executing the process as designed. Guide the process implementation and process changes at the site/unit and provide ongoing… Show more PQS Site Business Process Manager: Proactively develops and manage changes in controlled processes and procedures as the organization evolves, industry practices change and/or regulations change to assure high quality standards with applicable laws, regulations, guidelines and Roche policies.Discrepancy Management System Site Business Process Manager: Ensures executing the process as designed. Guide the process implementation and process changes at the site/unit and provide ongoing support (first line) to business areas. Monitoring and trending of the discrepancy Management process performance to ensure that it meets customer needs and to foster continuous process improvements.Interim CAPA Management Business Process Owner for CAPA Continuous Improvement Conference in Basal, Switzerland.Provide support for SMEs for Annual Product Quality Review.Serve as a key contact for communicating controlled document and policy changes within/across the Roche Carolina organization.Participating member or the Daily Operations meeting for resource and production planning.Provide support and guidance during and following internal audits and external regulatory inspections. Support the internal inspection management program by serving as Lead Auditor for internal audits.Develop and facilitate site-wide Annual Good Manufacturing Practices (GMP) Training, Quality System processes (CAPA, Discrepancy Management, Change Control) Training and Lead Internal Auditor Training.Sever as Subject Matter Expert (SME) on business initiatives involving systems, processes, procedures, regulations (CAPA, Discrepancy Management, Change Control) and system tools (TrackWise) intended for use compliance and continuous improvement activities.Provide regular updates to senior management functions and participate in the resolution of quality issues by fostering effective interdepartmental and cross-functional relationships. Show less

Responsible for sustaining the development, implementation, and improvement of an effective quality system designed to meet appropriate Business, Division, Corporate, Government, and international standards for efficacy, safety, and quality.  Ensured programs are consistent in complying with FDA Quality System Regulations (QSR), ISO 13485, ISO 9000, JPAL (and similar) standards for all of BD Diagnostics - NC's IVD and/or medical device products.  Developed and implement… Show more Responsible for sustaining the development, implementation, and improvement of an effective quality system designed to meet appropriate Business, Division, Corporate, Government, and international standards for efficacy, safety, and quality.  Ensured programs are consistent in complying with FDA Quality System Regulations (QSR), ISO 13485, ISO 9000, JPAL (and similar) standards for all of BD Diagnostics - NC's IVD and/or medical device products.  Developed and implement strategies, policies and procedures to carry out the BD Corporate and BD Diagnostics - NC quality policies. Developed, administered, documented and maintained the BD Diagnostics - NC Quality System for conformance to regulatory requirements and company policies. Developed and delivered site-wide compliance and Quality System training for BD Diagnostics - NC. Developed and promoted continuous quality improvement activities through effective utilization of the CAPA system as well as direct involvement in all situation analysis processes. Hosted and participates in external audits by regulators, notified bodies, or third party auditors. Facilitated Quality System Management Review meeting to support the management review process. Ensured MDR, Vigilance and Canadian reporting requirements are met. Ensured effective and compliant field action decisions and oversee the execution of the action for Class I, II, and III Medical Devices. Show less

Responsible for providing GxP and compliance services to clients in the Medical Device, Pharmaceutical and Biotech industries. Coordinated activities during GxP product and process audits; prepared inspection instructions, systems and procedures to ensure audit results are incorporated as required. Investigated non-conformances and analyzed causes of defects and provided recommendation of corrective actions for issues raised during GxP audits and compliance investigations. Manage the planning… Show more Responsible for providing GxP and compliance services to clients in the Medical Device, Pharmaceutical and Biotech industries. Coordinated activities during GxP product and process audits; prepared inspection instructions, systems and procedures to ensure audit results are incorporated as required. Investigated non-conformances and analyzed causes of defects and provided recommendation of corrective actions for issues raised during GxP audits and compliance investigations. Manage the planning and execution of all critical success factors within the project, i.e. scope, time, cost and quality. Coordinate validation projects throughout the entire life cycle - from proposal to final project handover. Assure that product and process validations meet regulatory, local, and corporate requirements. Develop Validation Plans and Maintain Master Validation Plan: Develop and execute IOPQ Protocols. Participate in new product and process development to assure Validation is addressed and arranges the QA tests required by the Validation protocols. Show less

Responsible for performing incident investigations to identify compliance and/or other failures and establish an agreed upon corrective action plan to resolve identified issues. Developed a system for tracking, filing, and maintaining the list of Approved Suppliers. Maintained and supported ongoing assessment processes for service providers. Assigned criticality for all service providers; Evaluated probable vendors to be audited. Conducted GxP audits of the functions within the Operations… Show more Responsible for performing incident investigations to identify compliance and/or other failures and establish an agreed upon corrective action plan to resolve identified issues. Developed a system for tracking, filing, and maintaining the list of Approved Suppliers. Maintained and supported ongoing assessment processes for service providers. Assigned criticality for all service providers; Evaluated probable vendors to be audited. Conducted GxP audits of the functions within the Operations Compliance organization and prepared reports of the audit findings for distribution to responsible personnel and management. Prepared and approved investigations / root cause analysis, CAPA documents and tracking CAPA items to completion. Prepare Quality System reports, including corrective actions and Quality Incidents. Interfaced with internal and external (to US Site Ops) customer departments during all phases of, investigations and CAPA implementation. Maintain GMP, GLP and GCP audit documentation for internal/external audits as well as CAPA Show less

Responsible for compiling, measuring and analyzing process improvements; Conducting quality system audits/process reviews, providing customer interface, and ensuring preventive and corrective action. Served as an in-house consultant to quality improvement efforts. Provided training and technical assistance as requested/needed by teams such as development, maintenance, and reporting of Key Performance Indices (KPIs). Develop and deliver training sessions and/or components of training as… Show more Responsible for compiling, measuring and analyzing process improvements; Conducting quality system audits/process reviews, providing customer interface, and ensuring preventive and corrective action. Served as an in-house consultant to quality improvement efforts. Provided training and technical assistance as requested/needed by teams such as development, maintenance, and reporting of Key Performance Indices (KPIs). Develop and deliver training sessions and/or components of training as directed and make presentations and/or assist in making presentations and coordinating group activities during training. Show less

Assured that no product is released until its quality has been held in accordance GCP, GLP, and cGMP and other applicable regulations. Conducted audits of the functions within the Vaccine Development Department and prepared reports of the audit findings for distribution to responsible personnel and management. Conducted investigations and corrections for incomplete/unexplained issues found during the record review process. Tracked and ensured completion of corrective actions resulting from… Show more Assured that no product is released until its quality has been held in accordance GCP, GLP, and cGMP and other applicable regulations. Conducted audits of the functions within the Vaccine Development Department and prepared reports of the audit findings for distribution to responsible personnel and management. Conducted investigations and corrections for incomplete/unexplained issues found during the record review process. Tracked and ensured completion of corrective actions resulting from record issues Assist with the trending of issues not requiring an investigation or Non Conformance Report. Show less

Responsible for maintaining the highest quality standards for finished goods by ensuring that all processes comply with cGMP, LHP, FDA and Customer guidelines; Conduct root cause investigations and complete reports of non-conformances that occur during the operational process. Developed / progressed CAPA’s, wrote / approved Nonconformance and Deviation reports; Quality Assurance representative for the Materials Review Board (MRB). Quality Assurance representative for Validation team for the… Show more Responsible for maintaining the highest quality standards for finished goods by ensuring that all processes comply with cGMP, LHP, FDA and Customer guidelines; Conduct root cause investigations and complete reports of non-conformances that occur during the operational process. Developed / progressed CAPA’s, wrote / approved Nonconformance and Deviation reports; Quality Assurance representative for the Materials Review Board (MRB). Quality Assurance representative for Validation team for the LIMS system (21 CFR 11 compliant); Recognized a need for new modified work procedures by creating, validating, and implementing a MS Access database for the purpose of tracking the status of Packaging Batch Records. Created and implemented electronic logs MS Excel for quarantined material, process deviation notifications, and batch record receipt streamlining; Demonstrated leadership capabilities by organizing and implementing the daily workflow regiment of the QA Documentation Specialists group based on the business needs as stated by the Customer Service and Planning departments through failure mode and effects analysis. Incorporated tools, such as PBR (Packaging Batch Record) Tracking (MS Access Database) for closed system use for affected departments; recognized a need for departmental improvement by coordinating interdepartmental office moves. Executing the plan was budgeted with great cost effective measures by soliciting the aid of other departments within the company; Selected by QA Management to provide 1st shift leadership, overseeing 5-15 individuals, and assuring effective and efficient workflow to execute supply chain support, providing positive feedback and direction to Packaging Supervisor. Show less

Responsible for specified testing of different raw material intermediate components (in-process), bulk and finished goods for sterility, endotoxin, bioburden submitted to the laboratory for analysis to determine the acceptability of the material or product. Collected and analyzed environmental monitoring samples (air, surface and water) from manufacturing sites in order to monitor cleanliness of the manufacturing facility in addition to testing finished product (sterility, endotoxin… Show more Responsible for specified testing of different raw material intermediate components (in-process), bulk and finished goods for sterility, endotoxin, bioburden submitted to the laboratory for analysis to determine the acceptability of the material or product. Collected and analyzed environmental monitoring samples (air, surface and water) from manufacturing sites in order to monitor cleanliness of the manufacturing facility in addition to testing finished product (sterility, endotoxin, bioburden) for stability to support date claim and sterility testing via the BacT/Alert Incubation System. Show less