Quality Engineer Auditor

Parveen Nijhawan

QA professional with extensive experience in Quality Assurance, Data Review/Analysis, Quality Investigations, Validation, Quality Compliance, Technology transfer, Internal and External Auditing, FDA regulations, and Quality Control in the Pharmaceutical and Medical Device industries with a proven track record of collaborating and innovating to achieve successful results for internal and external clients.

Core Competencies

Skills: FDA, Corrective & Preventative Action (CAPA), Deviations related to QMS, Change Control, GMP, GCP Audits, ISO-9001, ISO 13485, ISO-14971, 21CFR 820, Tech Transfer, APRs, USP, EP, & ICH Guidelines, Compliant Management, MHRA, Analytical Methodologies Tech Transfer, Corporate and internal audits, product release, Contract Manufacturing, and Project Management.

Software: Proficient in Microsoft Project, EtQ, Trackwise, Veeva Vault, Adaptive QUMAS, Doc-Man, Infinity, eQRMS, Compliance Wire, SAP SuccessFactors,

Experience

Sr. Investigation Specialist (Contractor) October2022-March2023

J&J-Raritan, NJ

Ensured all non-conformances are fully investigated and effective corrective/preventive action (CAPA) implemented timely

Provided Quality/Compliance guidance to resolve quality related issues

Represent the department in interdepartmental meetings in support of process improvement initiatives

Worked with management to address and remediate issues

Provided recommendations for the improvement of processes by working cross-functionally with different departments.

Quality Assurance Consultant

Azzur Group – Princeton

Oct2021– Sept 2022

Azzur Group is a premier professional service provider for the Health and Life Sciences industry. Key services include Engineering, Regulatory Consultation & Remediation, Project Management, Business Strategy, and Technical Services

Sr.Investigational Specialist (CTDO)

Bristol Myers Squibb – Summit, NJ (Contractor)

Manages the Change Control Process, CAPA, and Deviation Quality System for all GMP activities and works with responsible cross-functional areas to ensure timely completion.

Process improvements to existing methods/Establish best practices for current SOPs

Assist with overseeing inefficiencies deviations, and help reduce the backlog of deviations of the existing EMS System

Developing Blueprints and Templates for Different Trending Deviations in CTDO

Coaching and providing Guidance to CTDO Manufacturing & Lab. Teams on classifying, reviewing, and writing Trending Deviations

Supports Quality Systems harmonization efforts.

Develop risk Management documents, SOPs, Work Instructions, Templates

Communicates effectively with cross-functional stakeholders on matters related to the change control process

SME support during internal and health authority inspections of the facility

Project Manager, (Clinical, R & D) Mar2021– Sept 2021

Bristol Myers Squibb – Princeton, NJ.

Review & evaluate SOPs related to Global Development Operations, Clinical Trial Planning and Alliance Management, Clinical Trial Business Partnerships (CTBP), Global Vendor Oversight & Operations

Developing Procedural Documents as well Working Instructions for high level principles-based documents.

Process improvements to existing methods/ Establishing best practices for current SOPs

Support vendor assessment risk mitigation and audit/inspection Corrective Action and Preventive Action (CAPA) response & Management

Provide guidance and support for CRO oversight and issue resolution

Project management of vendor assessment & due diligence activities of all GDO vendors

Complete and/or assist with final due diligence reporting

Support CTBP Functional areas in support of Audit/Inspection readiness and preparation

Support ongoing vendor process/operations documentation across CTBP vendors

Support ongoing vendor oversight and documentation across CTBP

Contribute expertise and support for internal and external governance meetings and quality councils. Support issue management and escalation.

Reorganize records in Controlled Repository

Compliance Specialist (Contractor) May 2020– Dec 2020

Bristol Myers Squibb – New Brunswick, NJ.

Reviewed, evaluated, and approved plant operating documents SOPs, change control, qualification reports, CAPA, and deviations and maintains documents in an organized and traceable manner.

Evaluated specifications, documents, protocols, and registrations and recommends action to assure regulatory compliance

Assured the site quality systems are in place to avoid any possible regulatory compliance areas as assigned

Ensured compliance with procedures, policies, and directives to avoid regulatory issues by performing Gap Analysis on Quality documents.

Provided advice and service to all operating departments to assure compliance with cGMPs and other regulations

Reviewed all CMC documents related to Laboratory, Manufacturing & QMS.

Reviewed Analytical method procedures and associated change controls

Reviewed SOPs related to Analytical Methodology for Analytical Method Validation, Analytical Method Transfer, Reference Standards, Critical reagents, and Compendia Affairs

Experience with electronic document management systems such as QUMAS, SharePoint, Documentum, TrackWise, Veeva-Vault (Infinity), Success-factors learning, and more.

Excellent oral and written communication skills.

Excellent team player as well proficient in working independently and meeting all timelines

Quality Engineer (CAPA) Oct2017-Feb2020 (Contractor)

Ethicon (Division of J & J), Somerville, NJ.

Conducted Investigations of supplier’s Incidents/Deviations and Product Quality Complaints. Ensure that all actions are verified and or validated.

Ensured that actions do not adversely impact finished medical devices. Identify and implement improvement opportunities to increase the efficiency and effectiveness of the corrective and preventive action system

Provided guidance and direction for NC Observations and CAPA investigations. Complete NCOs, and CAPAs as required to enhance the QMS

Conducted investigations of suppliers’ Incidents/Deviations and Product Quality complaints

Processed requests, ensuring owners are assigned and timely responses are provided in alignment with Quality goals

Reviewed and approve documents under Change Control ensuring Compliance with GMP, GDP, GTP, and regulatory standards such as ISO 13485, ISO 9001, ISO 14971, etc.

Assisted in the development of effectiveness check plans and ensure that all effectiveness checks are appropriate at assessing the effectiveness of closed CAPAs.

Ensured that Corrective Actions are appropriate for the elimination of Root Cause and preventing Reoccurrence.

Effectively managed and improved the CAPA process and system for tracking, trending & reporting

Responsible for the collection of and reporting of Quality Metrics on a Monthly, Quarterly, and annual basis

Assisted in ensuring FDA Readiness Plan for the facility. Provide support for all regulatory audits, internal/external inspections, and other audits. Responsible for Follow-ups on all related Operational findings

Support adherence to SOPs and policies and assist in ensuring that procedures reflect current practice

Participates in the completion of the Risk Assessment

Proficient in ADAPTIV, Tableau, COGNOS, & ETQ Reliance

Working knowledge of manufacturing processes and the ability to support supplier development activities, continuous improvement initiatives, and quality management tools

Provided guidance on Quality/Compliance improvements to other departments

Worked on complex investigations and coordinate technical teams to ensure sound experimental design, effective data analysis, identification, implementation, verification, and validation of CAPA actions.

Followed up with action owners on all action items until items are effectively completed and closed.

Responsible to comply with all Federal, State, local, and company regulations, policies, and procedures including Health, Safety, and Environmental compliance.

Supported and participated in cross-functional projects when assigned, facilitate technical innovations to enhance Quality Systems and support business goals, and assist with other Quality System activities as requested by management.

Senior Quality Auditor Oct 2005– Jun 2017

Catalent Pharma Solutions (Formerly Cardinal Health PTS) – Somerset, NJ.

Reviewed & Approved COAs and Stability reports for accuracy, completeness, and conformance with specifications.

Completed GCP and internal audits of method development and method validation, process validation, cleaning verification, and other projects.

Reviewed and Approved microbiological testing, environmental and facility test data, and reports.

Strong Analytical skills and 22 yrs. Of Analytical Laboratory Experience

Utilized in-depth Knowledge of drug development process including GMP, GXP, GCP Compliance regulations.

Participated in FDA & EU Inspections.

Expertise in troubleshooting various unit operations and analytical methods.

Manage and execute the transfer of Analytical & Microbiology Technology Methodologies from internal QC and Analytical Development Groups’ external CROs.

Managed and oversee outsourced activities, to ensure timely generation of high-quality data.

Reviewed and Approved all Tech Transfer-related documents

Perform post-release auditing on 10% of the laboratory notebooks generated during each prior month to ensure data integrity.

Reviewed and approved deviations, investigations, OOS, CAPA, follow-ups, corrections, tasks, change controls, and other Track Wise deviations & assist in Root Cause and CAPA determinations that are associated with the Analytical, Manufacturing, Facility, and Meteorology.

Assisted and conducted GCP audits, customer audits, corporate audits, internal audits, supplier audits, and regulatory audits as needed.

Vast experience in handling customers complaints and resolving to the end

Reviewed and approved Analytical Test Methods (ATMs) & Technical test Protocols (TTPs) and Specifications.

Conducted audits of Pharmaceutical Development to assure compliance with cGMP, and Corporate and Pharmaceutical Development SOPs in accordance with the internal audit program.

Assisted in conducting external audits of Catalent Pharma Solutions suppliers.

Reviewed, approved, and closed Change Controls requests.

Author, review, and approve area and job-specific SOPs.

Conduct internal GMP_GLP_GCP audits of laboratories or other GMP areas.

Provide QA support to Manufacturing Projects and Commercial Batches.

Audit executed Batch records for compliance with good documentation practices.

Attend GMP training programs to stay current with regulations.

Audited raw materials, facility logs, and release data.

Experience in QA Room releases, Line Clearances, Equipment Release, and AQL inspections.

In-depth knowledge of QM Principles and Tools, such as Root cause analysis, Quality Risk Management, and more.

In-depth knowledge of FDA, EP, and USP guidelines

Initiated Problem Reports when deviations are discovered and follow them to completion.

Prepared documentation needed to support the Pre-approval Inspection Program at the site

Prepared Annual Product reviews in support of FDA/GMP requirements.

Maintained & reported defined QA Dept. Metrics to Senior Management weekly.

Skilled in basic technologies (e.g., MS Office Application, Adobe Acrobat, Documentum, Compliance Wire.

Excellent communication & interpersonal skills.

Proficient in Microsoft Office including Excel, Words, and PowerPoint.

Demonstrated ability to multitask on different levels and prioritize responsibilities for maximum yield well within Timelines.

Trained New QA Auditors.

Sr. QA / QC Chemist / Scientist Feb 1985– Oct 2005

Merck (Formerly Schering Plough Corp) – NJ.

Developed and validated analytical test methods according to current ICH guidelines and prepared corresponding procedures, specifications, and validation protocols and reports.

Provided analytical support for pre-formulation/formulation studies, pharmaceutical development activities, and stability studies.

Performed cleaning validation and analytical technology transfer.

Reviewed and audited laboratory notebooks, stability data, and instrument IQ/OQ/PQ documents.

Member of Safety Committee and performed safety inspections, prepared inspection reports, and provided mechanisms for corrective action.

Analyzed raw materials, production intermediates, and finished products (Tablets, Capsules, and Syrups) release and stability samples.

Performed Laboratory investigations of OOS (Out of Specification) OOT (Out of Trend), Atypical results using Track wise software.

Used USP-NF and in-house methods for Assay & Degradation Products, Content Uniformity

Education

Master of Science (MS) in Biochemistry –

Illinois Institute of Technology (Chicago, Illinois)

Bachelor of Science in Biology & Chemistry

University of Delhi, (New Delhi, India)

Bachelor of Education in Biology & Chemistry

University of Delhi, (New Delhi, India)

Accreditations / Certifications

Excel Training Workshop

Completed Lean Six Sigma White & Yellow Belt Course

Business Writing Course

JMP Software Statistical Data Analysis course

Method development and Validation Assessment Course

***************@*******.***

Somerset, NJ

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