Quality and Compliance

Nirav B. Thakar

*** ******* ***** ******, ** ****7

Home: 732-***-****

Cell: 732-***-****

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

OBJECTIVE:

Self-motivated professional seeking a challenging position where I can

utilize my communication skills and auditing background.

Summary:

I have experience in a quality and compliance environment in the highly-

regulated GxP (GMP, GCP, and GLP) pharmaceutical industry. In addition, I

have extensive experience with the following Quality Systems: CAPA,

Document and Records Management, Complaints Management, Change Control,

Validation of products & processes, Product Release and GxP/Compliance

Training with a full understanding of GAMP 5. Broad range of exposures have

allowed for me to develop strong documentation, analytical, and technical

writing skills. Through my various experience, I have gained a thorough

understanding of FDA requirements, and become proficient with quality

assurance and auditing principles/procedures. These experiences have

brought additional development of my skills in high throughput data entry

and transactional systems, where first-time-right quality is paramount for

regulatory compliance.

EDUCATION:

Rutgers University, New Brunswick, New Jersey - Bachelor's Degree;

BS in Biotechnology/Nutritional Science - May 2010

PROFESSIONAL EXPERIENCE:

5/2013 to 2/2014- Quality/Compliance Excellence Associate - Novartis

East Hanover, NJ

2/2014 to Present - Quality Training Project Coordinator

. Project Management with a focus on Organization and Training.

. Develop clear data sets and analysis of massive amount of cross-

boundary data content in timely manner and with high level of

accuracy.

. Provide monthly and Year To Date (YTD) Dashboard for management team.

. Facilitate with global management to discuss purpose, scope, and

results of audit findings and activities.

. Analyzed and developed GCP Quality Assurance systems and process.

. Working on LMS clean-up project. LMS contains high volume data which

needs to analyzed and evaluated.

o Communicate across all business units to provide status and

update on all Novartis data.

. Responsible for preparing the Pharma Dev QA Quality Assurance Audit

Database (QAAD) for shut down and retirement:

o Follow up on SOP Deviations, audit reports, issue escalations.

o Investigate missing information and complete incomplete records.

o Close out SOP Deviations, CAPAs, and audit reports.

o Review Investigation site and system audit reports.

o Performed all activities in accordance with GxP.

. Work with outsourcing team on Supplier Quality Assessment (SQA) for

Computer System Validation area. The SQA is a multifaceted assessment

of CRO compliance and capabilities, covering system development

methodology, validation and 21CRF11 compliance.

. Perform gap analysis and risk assessment.

. Provided timely written reports of quality compliance status.

. Supported planning and performance of client and contractor GMP and

investigator site GCP audits.

5/2012 to 2/2013- Quality/Compliance Lead - J&J Raritan, NJ

. Provided oversight to ensure project team deliverables align with Q&C

expectations and address "Corrective Action / Preventative Action"

(CAPA) items.

. Compiled reports of audit results for senior management.

. Gained exposure to information security and network controls.

. Supported status and project management reporting.

. Identified project touch-points requiring corporate internal audit

("CIA").

. Approved all system test cases (pre- and post-execution) using HP

Quality Center.

. Managed entire testing team in India.

. Facilitated and supported Q&C compliance activities for the assigned

projects.

. Coordinated of audit/pre-audit activity including formulation and

management of CAPA-related activity.

. Implementation strategies align with Q&C objectives for relevant

activities.

. Reviewed and provided input into controlled documents.

. Gained understanding of Quality and Compliance (Q&C) expectations,

requirements, documentation and approach for projects.

. Fulfilled the applicable deliverables as prescribed by the systems

development lifecycle roles and responsibilities ("SDLC R&R") matrix

for the compliance role(s) defined by the SDLC R&R methodology.

1/2012 to 5/2012 - Quality Assurance - Amneal Pharmaceutical Branchburg NJ

. Analyzed and proposed, new or changing requirements and devise

strategies for their implementation, ensuring business goals are met;

liaise with other internal functions, industry bodies or regulators as

required.

. Developed a database using Microsoft Excel for audit reports, change

control, CAPA.

. Created internal process procedures and documents.

. Conducted internal systems and process audits.

. Executed the preparation, distribution, tracking and filing of

questionnaires to evaluate supplier quality systems for compliance.

. Developed requirements of edit checks to guarantee high data quality

and develop reports.

. Collaborated with cross functional departments to assure seamless

communication.

. Ensured to communicate company expectations and requirements to

suppliers.

. Updated the company standards and procedures and supported the

implementation of the new procedures.

. Trained and managed associates.

10/2010 to 6/2011 - Documentation Specialist/Validation Associate, Ranbaxy

Pharma, New Brunswick, NJ

. Identified, documented and distributed audit observations and issued

audit reports.

. Planned and conducted Quality audits, as lead or co-auditor.

. Designed and validated custom application, databases, and

spreadsheets.

. Managed and tracked change control flow and input required data.

. Maintained and developed an external manufacturing database including

batch records, certificate of analysis and investigations,

authorizations and electronic movement in SAP.

. Collaborated in the execution of the process validation and pre-

validation protocols.

. Facilitated companywide Quality and Compliance in relation to

manufacturing environments governed by cGMP's and CFR requirements and

performed various monthly reporting and training.

. Organized process validation report.

. Maintained TrackWise for the GMP area: Transactional data system.

. Generated regular metrics reports using Excel.

. Verified clarity, completeness, and accuracy of technical

documentation.

. Responsible to classify all deviations as critical or non-critical.

Community Service:

2012 - United States Public Health Service: Volunteer for Hurricane Sandy

Edison, NJ

. Assist USPHS in setting up shelter, dieticians and headquarters for

Hurricane Sandy victims.

2014 - Present - Novartis Mentoring Program: Volunteer, East Hanover, NJ

. Mentor for second grade students.

2008 - 2011 - Franklin-Somerset Rescue Squad

Franklin Park, NJ

. Evaluated patients assessments, obtaining vitals and performing wound

care and splinting

. Managed the weekend/holiday crew.

. Worked closely with operations and medical personnel including

paramedics and field supervisors.

2008 - Present - Middlesex County College Edison, NJ

. Head Tutor in Math and Science that was responsible for a staff of

seven.

. Chaired a transition program that helped student transition to a 4

year college.

Skills

Technical: Proficient in MS Visio & Project, Excel, Basic HTML, C++,

Trackwise, QAAD, HP QC, EDMS, Documentum, MS-Office, MS-Project, JD

Edwards, writing grant proposal, SAP, SharePoint, Saba, LMS

Lab: blotting, PCR, Dilutions, Gel electrophoresis, HPCL. Languages:

Fluent in Gujarati and Hindi

REFERENCES AVAILABLE UPON REQUEST

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