Sohinii Khanna

adwgyl@r.postjobfree.com

Phone #: 267-***-****

PROFILE:

A self-starter candidate with over 20 years in the pharmaceutical and biotechnology industries. Accomplished a variety of roles in Quality Assurance and solid experience working in drug development lifecycle from clinical to commercial.

Overall management of clinical quality assurance and clinical trial oversight.

International inspection readiness program (US, EU and Canada). Conducted mock-audits and readiness assessment in preparation of local regulatory routine or pre-approval inspections.

Managed FDA and DEA regulatory inspections and post-inspection activities, i.e., creation of inspection responses and/or reports for regulatory agencies during the inspection, close-out, and corrective and preventive actions.

Hands-on QA experience, with internal and external audits of Investigator sites/trial master files/ vendors/ safety audits/reporting, develop best practices, continuous improvement and manage the Quality Management System to ensure compliance with applicable regulations, policies, and procedures.

Responsible for maintaining GxP (GCP, GLP and GMP) compliance.

Implemented Electronic Document Management system and Learning Management System (Veeva)

Knowledge of drug development process, US FDA Regulations, IND, NOA, ICH (Including Good Clinical Practice Guidelines) and USP reference standards. Understands and applies the drug regulatory terminology, informed consent process, IRB, Investigator and Sponsor responsibilities.

Detailed practical knowledge of test procedures in FDA regulated environments, 21 CFR Part 11 regulation, Software Development Life Cycle Management and working knowledge of Documentum.

Strong leadership and mentoring skills, strong working ethic, ability to multi-task, attention to detail, excellent communication, follow up, judgment, interpersonal and organizational skills, and able to work independently and prioritize tasks.

PROFESSIONAL EXPERIENCE

Ascentage Pharma

Quality Assurance GCP Lead (AD to Director Pending) (30Aug2021 - Current)

•Function as QA Lead, leading and providing overall quality assurance strategies for the company's clinical development.

•Defining and executing overall quality assurance activities in collaboration with Clinical Development, Clinical Operation, Safety Reporting & Pharmacovigilance.

•Serving as an advisor for GCP, EU Directives, ICH and emerging US and global guidelines and regulations and applying in the company's clinical studies for the development of quality risk mitigation strategies.

•Performing Vendor Qualifications.

•Performing risk assessments to identify audit targets, establishing audit plan, conducting internal, investigational site and vendor audits, developing and maintaining audit tools, checklists, and authoring audit reports and other audit-related documentation.

•Ensuring timely communication of QA issues including critical audit findings, potential misconduct or issues of significant deviation to stakeholders and management.

•Working with relevant functional areas for CAPA plans.

•Defining and implementing the health authority inspection strategies in support of regulatory submissions and GCP Compliance.

•Hosting Health Authority Inspections.

•Authoring or reviewing QA SOPs and conducting training across functional areas.

•Implementing Quality management system (Document Management System, Learning Management System, CAPA and Deviation System).

•Performing Computer Management Validations.

•Other responsibilities as needed

Kyowa Kirin (Feb2015 – 25Aug2021)

GCP QA Manager/ Quality Systems Sr. Manager

Quality Assurance department, primary responsibilities include, but not limited to:

•Develop and implement all aspects of clinical quality assurance strategy for the international development organization. Develop a risk-based annual master quality plan including internal audits, vendor audits, written procedures, training program, CAPA and regulatory inspection readiness.

•Provide support for and/or lead during GCP regulatory inspections of Kyowa Kirin sites and Investigator Sites.

•Perform Investigator Site audits and draft reports for related clinical trials.

•Direct regulated training, written procedures, CAPA, computer system validation and investigational product authorization systems.

•Review and provide guidance for clinical trial protocols and other key trial related documents.

•Maintain an up-to-date understanding of regulatory quality requirements as well as industry trends and standards including issues relating to GCP and GVP. Interpret and advise on quality standards. Review and ensure existence of adequate QA policies and operating procedures. Author and/or revise policies and operating procedures as necessary.

•Represent QA on all clinical/development project teams and attend global QA committees. Negotiate with peer groups and work to resolve conflict on cross-functional issues regarding quality.

•Advise senior management regarding quality issues and continuous quality improvement initiatives. Prepare monthly operations reports and routine GCP quality system assessment reports.

•As a member of Clinical/Development Project Teams:

-Interpret and advise on compliance issues.

-Understand the relevant drug development QA environment and communicate the relevant requirements to the team.

-Plan, schedule, conduct & prepare reports and close audits of drug development to ensure conformance to regulations and Company written procedures.

-Audit and assess vendors with respect to relevant quality issues.

-Review and provide input on relevant documents in support of the development process.

•Develop and support company's internal quality management systems, e.g., systems for batch release and control, audits, policies and procedures, investigations and CAPAs, change controls, document management, and training management.

•Provide oversight and support for implementation and management of the eQMS system for the

N. America region.

•Manage system change requests for GxP systems, including ERP and eQMS systems.

•Support continual process improvement of company’s quality systems and implementation of new electronic Quality System processes as needed.

•Track performance of deviations, CAPA, Change controls, training, etc. and report to department/regional management.

•Maintain SOPs and coordinate biennial reviews of SOPs.

•Manage training records for N. America region employees. Develop and maintain training curricula.

•Create and manage training materials.

•Compile required information from both internal and external stakeholders to complete Annual Product Review reports for all N. America products.

•Develop and enhance policies and procedures related to quality management systems.

•Assist/lead during regulatory inspections of Kyowa Kirin facilities and GxP contractor sites.

•Participate on cross-functional teams, as needed.

•Provide periodic updates to senior management.

•Perform additional activities related to the Quality function as needed.

•Benchmark other quality and industry organizations to remain current with industry regulations and compliance trends.

• Manage direct reports and help them in their career development.

Joule Scientific (Client Jazz Pharmaceuticals) (Apr 2013 – Dec-2014)

QA Consultant

•Organize, maintain, update, and manage Quality Systems for audit reports, change controls, deviations/non-conformances, and CAPA.

•Support functional groups in development of standard operating procedures for all QxP activities, where required.

•Act as liaison between the company’s Quality Systems group and the functional groups for timely completion of all quality assurance related activities.

•Identify deviations that impact product disposition, work with contract manufacturers to resolve issues.

•Perform audits of vendors (CMO, CRO and Labs).

•Maintains the Internal Audit and External Audits Schedule for the whole company follow up with the auditors for timely completion and also a liaison between the company and Contract Manufactures, Clinical Research, etc.

•Act as a liaison person between PV and QA also contact the places from where complains come to do understand the nature of the complaint and as well as to do the investigation.

•Report the metrics to the upper management in a monthly basis.

Bard Holding (Nov 2011 – Apr 2013)

QA Consultant

•Review and approve SOPs for the Production.

•Establish overall production strategies for Morrisville and all plant locations.

•Implement Production and Quality Standards.

•Implement and established all processing equipment.

•Implemented the QMS system for the company (CAPA, Deviation, LMS, Doc. Management).

•Perform vendor’s audit.

Merck (West Point, PA) (Jun 2010 – Nov 2011)

QA Consultant

•Management of SOPs for the entire company.

•Audit documents for accuracy and relevancy.

•Coordinate and maintain training timeline table for each department and functions.

•Review and approve the manufacturing batch records using MIDAS system.

•Manage and maintain CAPA in track wise system till closure.

•Coordinate with production, manufacturing and QA departments to review documents and make the final approvals.

Medarex (Annandale, NJ) (Jun 2009 – Jun 2010)

DQA Record Reviewer

•Issue and review manufacturing and QC testing batch records for biologic pharmaceutical product as per the company SOP’s.

•Handle product complaints evaluate product quality complaints for seriousness, correctness and consistency, review batch records, analytical data, all kinds of deviations, prepare weekly and quarterly product complaints reports.

•Prepare release protocol as well as interact with production/quality control to resolve any discrepancies and/or report non conformance, review laboratory test including biochemistry, Immunology, Microbiology and Development for in-process, release and product stability.

•Review of static data and approval of test samples and Release samples in LIMS.

•Train other employees.

•Review GLP toxicology batch record and review on quality control data.

Spectraforce, Raleigh, NC (Position in Philadelphia, PA) (Aug 2008 – May 2009)

Client – Merck & Company, Inc. (West Point, PA)

Document Control Consultant in cGXP Environment

•Code for raw materials and SMF formula used for vaccines in sterile, bulk bio, and culture media batch records using DocCompliance, Impact, PCCD, and Panagon systems to mitigate data for the new computer system MIDAS.

•Work on the SMFs, compare products that run in the same line to help make a prototype SMF for all the products that run.

•Maintain master SOPs list and other logs in the database.

Accumed, Inc., Lawrenceville, NJ (Jun 2007 – Jun 2008)

Quality Analyst and Documentation Consultant

•Audit existed documents for accuracy and relevancy.

•Work on QM, WM, MM modules of the SAP System

•Ensure accuracy and completeness of product complaints in accordance with regulatory compliance and specifications among multiple sites.

•Review investigations, customer reports, and trends of complaints

•CAPA system lead, developed CAPA system including effectiveness check.

Tech-Start, Cleveland, OH (Jan 2006 – Jun 2007)

Client – Bayer (Jan 2006 – Dec 2006)

Amgen (Jan 2007 – Jun 2007)

Quality and Validation Consultant

•Create, review, and execute IQ, OQ, and PQ protocols, SOPs.

•Follow applicable client, cGXPs(X=Laboratories, Clinical and Manufacturing) and company standards and procedures.

•Develop all of validation lifecycle documentation, including validation plan, SOPs and summary reports.

•Prepare documents of products for FDA approval and audits as well as manage customer complaints and investigations.

Intrasphere Technologies, Cleveland, OH (Sep 2004 – May 2005)

Client – Pfizer and Volk (Medical Device Company)

Quality Consultant

Information Systems Validation

•Review test plans, Quality Assurance plans, Functional Specifications, Detailed Design Specifications, Functional Requirements Specifications, Installation Qualifications, and Operational Qualifications.

•Execute Installation Qualifications and Operational Qualifications.

•Perform QC test on several test and production environments.

•Review documentation for accuracy and compliance and track customer complaint activity.

•Develop and implement training of Complaint Unit.

•Review Change Management documentation.

•Compile and submit regulatory documentation for existing 510k.

Rockwell Automation, Mayfield Heights, OH (May 2001 – Aug 2004)

Client – Merck, Gilford Pharmaceuticals and Baxter

Quality and Validation Consultant

Information Systems Quality Control and Validation

•Review and verify test plans, Quality Control Plans and test scripts, Functional Specifications, Detailed Design Specifications, and Functional Requirements Specifications.

•Review Validation Master Plan, Installation Qualifications, Operational Qualifications, Performance. Qualifications, Information System Vendor Audit Plan.

•Perform Information System Vendor Audit.

•Review Validation Summary Reports for Installation and Operational Qualifications.

21 CFR Part 11, FDA regulation for electronic records and signature

•Create/develop procedures to address all main elements of 21 CFR 11.

•Review/verify archiving, storage and retrieval records for accuracy.

•Review/verify Security and Audit trail.

•Review/verify Controls of identification codes/passwords change control documentation/records.

•Perform Vendor Audits and review Vendor Audit plans.

•Analyze vendor audit results and recommendations to management.

Global Management Consultancy LLC, Philadelphia, PA. (Aug 1997 – May 2001)

Quality Consultant

Quality Management System (ISO 9000)

•Perform pre-assessment audits of QMS in different industries based on ISO 9000 standards.

•Identify and define key processes and develop internal quality audit system.

•Develop Quality Manual for QMS.

•Lead for CSV activities.

•Review and verify test plans, Quality Control Plans & test scripts, Functional Specifications, Detailed Design Specifications, Functional Requirements Specifications.

•Review Change Management documentation.

EDUCATION:

•Bachelor’s in science (Biology), Utkal University, India

•Post Graduate Diploma in Human Resource from BHU (India)

•Certificate in Computer Application, Compubase, Philadelphia, PA

TECHNICAL SKILLS:

•21 CFR Part 11

•Computer System Validation

•Quality Management System (ISO 9001:2015)

•Information Systems / Technology

•Change Management

•Regulatory Submission (510k)

•Product Labeling

•ICH E6 (GCP)

•ICH Q10(PQS), Q9 (Quality Risk Management) and Q8 (Pharmaceutical development)

AFFLIATIONS:

Member, American Society for Quality, Member, Institute of Validation Technology

SOFTWARE EXPERTISE:

MS Office 2000, MS Windows 98/2000/XP, Visual Basic 5.0 and 6.0, Rockwell Software (RS View ME)

ORION, SAP (QM, WM modules), IMPACT, DocCompliance, MIDAS (Merck), LIMS, Reliance System

Veeva Vault System

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