Sanket Shah A. Email & Phone Number

• Manage and maintain Supplier Quality and Internal Audit Program compliance by performing GMP/QMS audits of Suppliers and Internal departments and make risk-based recommendations for the approval status of suppliers or compliance rating of internal departments and provide proposals for required risk mitigation.• Maintain auditee profiles in the relevant data systems and keep current records of internal and external audit files, including schedules, audit plans, audit evidence, and audit assessments. • Manage the CAPA process for the assigned programs/departments by ensuring that nonconformance and other reportable events as well as CAPA reports are recorded, followed up, tracked and trended.• Assess and endorse the appropriateness of auditees' corrective and preventive action (CAPA) plans.• Perform Risk Assessments on suppliers/procured materials to support release decisions where required and approve risk assessments authored by internal auditees.• Approve supplier Quality Assurance Agreements (QAAs), and subsequent amendments, guiding negotiations of supplier QAAs, and assess changes proposed by suppliers or internally that have a potential impact on the supplier approval status.• Host and coordinate external audits by customers and/or regulatory agencies.• Coordinate collation of responses and corrective actions from external audits with relevant programs and/or departments to ensure timely resolution of observations and issuance of responses.• Serve as a resource to internal stakeholders (such as Procurement, and Technical) for the interpretation of applicable regulations and guidelines.

Toronto, Ontario, Canada

• Managed the internal cGMP audit function to verify that all company sites, Contract manufacturers (CMO), Testing Labs and Suppliers meet current regulatory and Company requirements.• Provided Quality oversight of CMO’s for ALLMAX distributed products at the validation, launch, and commercial stages of the product life cycle.• Maintains Product Quality by enforcing Quality assurance policies and procedures and regulatory requirements, collaborating with other members of management to develop systems and training methods.• Ensure review of batch documentation and disposition of CMO’s manufactured product shipments for distribution in the US market.• Handled Laboratory deviations and out-of-specifications and developed CAPA to avoid recurrence.• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures. Provide timely, concise communications to functional and executive leadership regarding project status and pending issues.• Evaluate changes to the dossier to determine the need for amendments.• Conduct and prepare detailed investigations or quality reports and respond to requests. Address non-conformances and change controls to offer regulatory affairs updates to QA metrics.• Performed root cause analysis and implemented Corrective and preventive Actions (CAPA) to mitigate non-compliance following regulatory guidelines. Prepare and review Change Control Documentation, CAPAs, Deviations, and Risk Assessment reports.• Provide leadership and direction to assigned direct reports, and ensure objectives are assigned and followed up. Plan workload in assigned areas and distribute equitably to direct reports. Manage and provide performance feedback for direct reports. Prepare QA budget and manage departmental expenses.

Toronto, Ontario, Canada

• Write, analyze, and edit technical documents to support country-specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in the USA, Canada, and Europe• Managed regulatory change required by new and revised laws and regulations, communicating complex requirements, and identifying operational impacts.• Organized and maintained all files related to regulatory actions.• Implement Quality Assurance procedures as per internal requirements and/or client contractual requirements.• Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc.• Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports.• Support approval in other regions as required.• Assist in preparing responses to regulatory authorities' questions within assigned timelines.• Stay abreast of regulatory procedures and changes in regulatory climate.• Assess device-related incidents/complaints for medical device reporting requirements.• Compile and submit reportable events to relevant regulatory authorities in a timely manner.• Handle recalls and field actions, if required• Support external regulatory agency audits, providing regulatory input to minimize the potential for findings of non-compliance.• Assist in preparing clinical trial site ethics review board applications for investigational device trials.• Juggled multiple projects and tasks to ensure high-quality and timely delivery.

Bridgewater, New Jersey, United States

• Managed all aspects of the Quality Assurance (QA) review for applicable records (i.e. Production Batch, Laboratory) and pertinent disposition of components, materials and finished products.• Reviewed and evaluated current operations of the Record Review group monitoring indicators such as cycle time, productivity, standard hours backlogs, and overdues. Adjust operations to assure sustained compliance and effective department performance.• Administered the systems for issuance and distribution of Quality Release documentation such as Certificates of Analysis for products.• Established product specifications and quality assurance practices. Monitored product trends and suggested changes. Handled scheduling procedures for the department and directed team members in setting and achieving goals.• Reviewed standard operating procedures or quality assurance manuals to refine production processes or update them for conformity to new regulations or policies.• Identified deviations in finished products from quality standards, isolating causes within the production process and devising solutions to increase consistency.• Handling of unplanned deviations (Notice of investigations) related to manufacturing, engineering, regulatory and quality control.• Create new and periodically review systems and procedures (SOPs) by analyzing operating practices, record-keeping systems, forms of control, and budgetary and personnel requirements.• Monitored execution of testing activities, directing supervisors, inspectors, and floor workers according to testing specifications to gather accurate, useful data.• Created and wrote manuals on production processes for new production lines, adapting standard operating procedures to consistently achieve order specifications.• Ensure the accuracy and integrity of protocols, reports and documents generated to meet the requirements and support documentation during regulatory inspections and client audits.

Bridgewater, New Jersey, United States

• Recommended and implemented measures to improve production methods and quality of products.• Monitored equipment, checked supplies, and coordinated manpower to meet expected demand.• Established and updated production schedules to meet changing demands.• Monitored staff training and output to meet compliance, productivity, and revenue goals.• Oversaw continuous improvement initiatives in a Lean environment to drive gains in quality, flow, and output.• Managed a team of QA Associates and inspectors to ensure adherence to product requirements.• Maintained top-notch quality control standards and eliminated downtime to maximize revenue.• Developed and implemented significant process improvements to enhance department quality and throughput.• Monitored manufacturing variances to achieve quality improvement while resolving product process and equipment problems.• Coordinated production requirements with material handling and staffing functions.• Assist with measures to improve efficiency by 20% by presenting performance data reports to management and revising procedures.• Assist in detailed product quality investigation where necessary by participating in root cause analysis and providing any observations noted during the manufacturing process.

Bridgewater, New Jersey, United States

• Handled all shop floor functions and BPR Review • Prepared and reviewed Annual Product Quality Review Reports.• Prepared Specifications and procedures for AQL for QA in-process, finished products, and packing materials.• Investigated and assured corrective action on customer complaints about product quality following cGMP, which emphasizes continuous improvement.• Handled deviations, incidents, QA Systems and Documentation• Reviewed and executed Process and Cleaning Validation Protocol.• Assisted in detailed product quality investigation for root cause analysis and providing any observations noted during the manufacturing process.

•Maintain critical process parameters according to SOPs to maintain quality•Maintain and review documents related to raw materials, intermediate & finished products such as BMRs, QC results, cleaning test results•Monitor, evaluate and interpret data from all phases of design and development of a product formulation from raw material to finished product•Prepare solid dosage prototypes, Co-ordinate new products formulation development and reformulate existing product formulations as required to suit customer needs•Prepare various documents like SOPs, validation protocols, cleaning verification documents under guidance for Biopharmaceutical equipment using single use technology•Optimize ingredient functionality, product functionality, product formulations and product enhancement to improve quality, cost, and manufacturing of new and existing products for customers•Performs laboratory bench work and provide technical support to customers for scale up formulations using existing APIs to suit their needs

Master Of Science, Pharmaceutical Manufacturing

Activities and Societies: International Society of Pharmaceutical Engineers (ISPE)Course Work: -Validation and Regulatory Affairs.

Bachelor'S Degree, Pharmacy

Activities and Societies: Student Representative in Student Central Committee; Joint Secretory for Library Committee

High School Diploma, Science