Bina Patel
Global Manager, Quality Compliance & Audit System - Corporate at Apotex Inc.
Summary
Highly skilled Quality Assurance professional with 17-years of experience in the pharmaceutical/Nutraceutical industry. Extremely knowledgeable in overall Solid dosage manufacturing process ,Quality Assurance Compliance functions and Quality management system. Hosted FDA and Health Canada inspection. Experienced with Consent decree process handling. Possess the ability to interest and convince others when changes are required. Presentation and technology leading skills, results-oriented person. Tactful team player with excellent people skills. Highly adept at managing multiple priorities.Developed and implemented Incident investigation, CAPA, Change control ,External /internal audit, Stability, Annual product review and Customer complaints quality systems.Familiar with GMP ,Health Canada guideline, MHRA, EU, ICH, GCP ,GLP and 211 CFR .
Certified Quality Control Practitioner
Certified Quality Control Practitioner
Experience
Global Manager, Quality Compliance & Audit System- Corporate
Apotex Inc.
Responsible for the development, implementation, maintenance and improvement of systems
supporting the Corporate Quality Audit function. Monitors adherence to the Quality Audit Schedule,
updating and reporting metrics and trends. Tracks execution of individual audits. Analyses data,
identifies risk and escalates concerns appropriately. Coordinates teams across boundaries. Supports and contributes to the Corporate Quality as required.
Manages requests for Due Diligence visits/audits and ensures requests are appropriately supported along with the Global Quality Audit Schedule.supporting the Corporate Quality Audit function. Monitors adherence to the Quality Audit Schedule,
updating and reporting metrics and trends. Tracks execution of individual audits. Analyses data,
identifies risk and escalates concerns appropriately. Coordinates teams across boundaries. Supports and contributes to the Corporate Quality as required.
Coordinates and assists, across boundaries, Managers, Senior Auditors and Auditors in the
planning and allocation of supplier audits according to the Global Quality Audit Schedule, tracking
and assuring adherence to the Schedule, and making efficient and effective use of resource.
Manages the Global Audit Schedule of Apotex sites, liaising and facilitating the audit timings and arrangements as required.
Tracks the execution of individual quality audits to assure compliance with Apotex SOPs and
Regulator expectations.
Responsible for suggesting/evaluating improvements to the audit system, making changes to the system, working with departments within and outside QA to improve quality as related to the
system, and training personnel on the system.
Works with the management to ensure the continuous development and improvement of supplier audit programs and systems.
Provide logistics support during inspections of regulatory agencies and customers, and provision of audit reports across boundaries.
Prepare, update and review proposed changes to SOPs, as required.
Ensure that all work is performed in full compliance with current Good Manufacturing Practices,
Standard Operating Procedures, all regulatory requirements, and established safety standards.
QA Compliance Manager
SUN PHARMA
Promoting quality achievement and performance improvement throughout the organization.
Manage the Quality Assurance Compliance specialists
Setting QA Compliance objectives and ensuring that targets are achieved.
Collating and analyzing of product performance data against defined parameters.
Review and Evaluate the Quality systems trending report.
Ensures the procedures are properly understood, carried out and evaluated and product modifications are investigated if necessary;
Provides the suggestion and needed changes for improvements to the process owner of SOP to ensure cGMP.
Driving the group to plan, formulate, and train on comprehensive quality procedures.
Incident investigation review and coordination.Facilitate Investigations and root cause analysis
Management of short and long-term corrective actions (CAPA).
Coordinate and Perform Internal audits
Compliance review of stability reports , OOS, OOT, and OOC.
Performs the compliance review of Instrument malfunction forms, Document change management form and Change control.
Coordinate the regulatory audits to ensure that guest auditors receive access to needed documentation and staff with minimal disturbance to ongoing operations.
Writing/revising and review of QA related SOPs.
Special projects as required.
Manage the Quality Assurance Compliance specialists
Setting QA Compliance objectives and ensuring that targets are achieved.
Collating and analyzing of product performance data against defined parameters.
Review and Evaluate the Quality systems trending report.
Ensures the procedures are properly understood, carried out and evaluated and product modifications are investigated if necessary;
Provides the suggestion and needed changes for improvements to the process owner of SOP to ensure cGMP.
Driving the group to plan, formulate, and train on comprehensive quality procedures.
Incident investigation review and coordination.Facilitate Investigations and root cause analysis
Management of short and long-term corrective actions (CAPA).
Coordinate and Perform Internal audits
Compliance review of stability reports , OOS, OOT, and OOC.
Performs the compliance review of Instrument malfunction forms, Document change management form and Change control.
Coordinate the regulatory audits to ensure that guest auditors receive access to needed documentation and staff with minimal disturbance to ongoing operations.
Writing/revising and review of QA related SOPs.
Special projects as required.
Assistant Manager,QA compliance
SUN PHARMA
• Maintain Quality system such incident, CAPA, Change Control
• Coordinate and lead product/process investigations.
• Participate in Internal audit
• Monitor compliance status within the manufacturing plant and distribution center.
• Tracking, trending and monitoring of quality system (Complaint, investigation incident, CAPA, change request)
• Prepare quality system trend reports by collecting, analyzing and summarizing data and trends
• Provides reports to senior management as requested, tracks and reports on quality and performance indicators
Direct supervision of QA compliance specialists
Responsible for issuance of QA documents and/or review of the various document types submitted to the compliance function.
Manage multiple projects
• Creation of Standard operating procedure
Department Training Coordinator (QA)• Coordinate and lead product/process investigations.
• Participate in Internal audit
• Monitor compliance status within the manufacturing plant and distribution center.
• Tracking, trending and monitoring of quality system (Complaint, investigation incident, CAPA, change request)
• Prepare quality system trend reports by collecting, analyzing and summarizing data and trends
• Provides reports to senior management as requested, tracks and reports on quality and performance indicators
Direct supervision of QA compliance specialists
Responsible for issuance of QA documents and/or review of the various document types submitted to the compliance function.
Manage multiple projects
• Creation of Standard operating procedure
• Developing Training Module of Quality department
• Developing Employees qualification Matrix as per their job description
• Sets performance objectives and regularly evaluates employee performance to ensure they are meeting both current and future needs
• Scheduling and performing department orientation
• Conducting training of Quality system SOP Incident Investigation
• Perform QA oversight of manufacturing area, such as reviewing cleaning log book, line clearance, and room clearance.
• Backup QA Supervisor as needed
• Review third party investigation report and Review Corrective action report and Initiated corrective action plan
• Worked with Consultants/FDA on Seize inventory release
Senior Quality Assurance Engineer
Caraco Pharmaceutical Laboratories ( Sunpharma)
• Major responsibility is to enhance and ensure consistent application of quality standards, systems and processes in the manufacturing process.
• Investigates all manufacturing issue and Quality incident, non conformance and prepare the investigation report and recommend the corrective action to prevent re occurrence.
• Monitor and follow up on all incidents.
• Ensure the facility in Compliance to cGMP standards
• Investigates all manufacturing issue and Quality incident, non conformance and prepare the investigation report and recommend the corrective action to prevent re occurrence.
• Monitor and follow up on all incidents.
• Ensure the facility in Compliance to cGMP standards
QA Assoiciates
Accucaps Industries Ltd.
• Investigates all manufacturing issue and Quality incident non conformances
• Perform line clearance checks
• Perform Visual defects AQL inspections,
• Perform Daily Compliance audits
• Perform In process auditing on all documents communicating results and escalating serious incidents.
• Perform line clearance checks
• Perform Visual defects AQL inspections,
• Perform Daily Compliance audits
• Perform In process auditing on all documents communicating results and escalating serious incidents.
QA auditor
Gelcell
POSITION: QA Auditor
• Ensuring manufacturing, packaging, labeling & holding operations are performed in a manner that prevents adulteration or mislabeling of any product/ raw materials and finished products meet specifications for identity, purity, quality, strength and composition prior to release of Final product.
• Conduct Self-inspections for Facility, equipment, Laboratory to ensure facility in CGMP standard and recommend system to improve production efficiency and quality for continuous improvement
• Investigate issues ,quality and respond to customer complaints .Monitor and follow up on deviation and proposes and approve corrective actions to compliance with regulations and quality
• Issue Rework & Reclaim Documentation.Perform AQL inspection on Finish product.
• Responsible for conducting GMP training for all new employees, existing employees and assuring a high level of GMP competence within the facility and Maintain employee training records.
• Ensuring manufacturing, packaging, labeling & holding operations are performed in a manner that prevents adulteration or mislabeling of any product/ raw materials and finished products meet specifications for identity, purity, quality, strength and composition prior to release of Final product.
• Conduct Self-inspections for Facility, equipment, Laboratory to ensure facility in CGMP standard and recommend system to improve production efficiency and quality for continuous improvement
• Investigate issues ,quality and respond to customer complaints .Monitor and follow up on deviation and proposes and approve corrective actions to compliance with regulations and quality
• Issue Rework & Reclaim Documentation.Perform AQL inspection on Finish product.
• Responsible for conducting GMP training for all new employees, existing employees and assuring a high level of GMP competence within the facility and Maintain employee training records.
QA Manager
Suntrition Inc.
Responsible for biological and chemical evaluation of raw materials, intermediate products, final product, packaging and production facilities. Includes writing and establishing specifications, preparing the certificate of analysis for finished product.
Responsible for all activities involving quality assurance and compliance. This includes audits / inspections, checks and tests for quality control for the manufacture of products.Participates in research and development activities. This includes development of new formulations, evaluation of chemical and physical properties of active ingredients and excipients.
Participates in quoting, purchase order scheduling and purchasing. Analyses changes or new issues in materials and supply to reduce costs and improve quality. Source the raw materials. Adjusts inventory and forecasts for purchasing. Creates formula as per customer request or suggests methods for better quality.
Technical advisor for Production, Quality and Sales. Technical resource for customers, addresses customer technical needs to ensure customer satisfaction.
Preparation of documents and arrange shipping method for product.
R&D and Process developments
Develop methods to improve production efficiency and quality. Advise Technical Support to Product Development. Recommend better excipents for compressing of tablets and filling of Encapsulation with maintaining the budget and quality. Preparing Master Ingredient sheet for Proposed Product’s of Customer Quotation
Education
University of Windsor
Bachelor's Degree, Chemistry(Biology, Genetics, Ecology, Botany and Statistics)
St.Clair College
Quality control Practitioner Certificate, Basic and advanced Statistics & SPC, Quality Concepts,Essentials of quality Managements, Auditing
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