Project Management Data Entry

AVANISH RAJ

Email: *********@*****.*** Phone: 201-***-****

Residency Status: Green Card

CAREER OBJECTIVE

To secure a challenging leadership position where my diverse experience in Quality Control Project Management, and my background across various industries can contribute significantly to the success of the organization.

EXPERIENCE SUMMARY

Industries: Pharmaceutical, Biotech, Medical Device, Clinical Trials, Clinical Research Organizations (CRO), Optical, Tobacco and Food

PROFESSIONAL EXPERIENCE

Pharmaceutical Industry

SAR Technologies, LLC (Client: Johnson & Johnson)

Role: Q&C Lead / Project Management Lead

Duration: September 2022 – Present

Responsibilities:

Develop end-to-end project strategies and assist teams with SDLC deliverables

Provide weekly project status reports, including risks, to senior management

Conduct system and requirements risk assessments, adopting a risk-based approach to validation

Lead testing and documentation sessions with cross-functional teams

Collaborate with business, IT, and vendor teams to ensure compliance with regulatory guidelines

SAR Technologies, LLC (Client: Catalent Pharma Solutions)

Role: Quality Lead

Duration: January 2017 – December 2017

Responsibilities:

Review and approve validation deliverables for JDE V9.1 upgrade globally using Valgenesis tool

Review design documents and test scripts to support continuous improvement initiatives

Conduct training for Test Script Authors, SMEs, and testers

Oversee periodic reviews of system compliance with company and regulatory standards

Additional Pharmaceutical Experience:

McNeil (Johnson & Johnson): Q&C Lead (October 2012 – February 2015)

Reed Technologies: Business Analyst/Validation Lead (January 2012 – March 2012)

Wyeth (Pfizer): Q&C Lead (December 2010 – December 2011)

Pfizer: Validation Analyst/Software Tester (October 2005 – December 2005)

Biotech Industry

SAR Technologies, LLC (Client: Autolus)

Role: Validation Lead

Duration: January 2021 – September 2021

Responsibilities:

Perform risk analysis of systems and requirements

Review vendor documentation and create validation deliverables based on Validation Plans

Coordinate project meetings and ensure project timelines are met

Provide regular walkthroughs of system functionality with quality leads

SAR Technologies, LLC (Client: Sanofi – Bioverativ)

Role: Validation Lead

Duration: January 2018 – December 2020

Responsibilities:

Generate validation deliverables based on Validation Plans

Coordinate with team members to meet project timelines

Create and close change controls using internal change control systems

Collaborate with quality leads for system walkthroughs and compliance reviews

Tobacco (e-Cigarette) Industry

SAR Technologies, LLC (Client: Juul Labs, Inc.)

Role: Q&C Lead / Audit Lead

Duration: September 2021 – September 2022

Responsibilities:

Perform internal audits of computer systems and facilitate meetings with stakeholders

Review vendor documentation and validate project deliverables

Ensure all team members and third-party personnel are trained on Juul’s policies and procedures

Participate in developing Juul’s Data Integrity policy framework

Medical Device Industry

Infomerica Inc (Client: Ortho Clinical Diagnostics)

Role: Q&C Lead

Duration: September 2015 – May 2017

Responsibilities:

Ensure compliance with 21 CFR Part 11 and Part 820 through quality reviews

Mentor team members on reviewing and approving validation deliverables

Develop Q&C guidelines and test script authoring/execution documents for a global audience

Lead offshore teams to ensure compliance during testing phases

Infomerica Inc (Client: Zimmer-Biomet)

Role: Program Manager & Engagement Lead

Duration: February 2015 – September 2015

Responsibilities:

Manage multiple validation projects with budgets up to $2 million

Lead a team of ten consultants across various roles (Validation Analysts, SMEs, Project Managers)

Collaborate with business units to meet project timelines and deliverables

Identify gaps in Policies and Procedures and draft corrective SOPs

Additional Medical Device Experience:

Invacare: CSV Specialist/Validation Lead (April 2012 – September 2012)

Synthes (Johnson & Johnson): Validation Lead (July 2009 – December 2009)

Clinical Trials Industry

Infomerica Inc (Client: ePharma Solutions)

Role: Sr. Validation Analyst / Validation Lead

Duration: March 2010 – September 2010

Responsibilities:

Assist pharmaceutical companies in managing Clinical Trials and regulatory documents

Review and update existing SOPs and SDLC processes

Validate clinical trial applications (SDE, eMVR, UMA, IMPACT, ETL)

Clinical Research Organization (CRO)

Infomerica Inc (Client: Covance)

Role: Validation Analyst

Duration: September 2006 – January 2007

Responsibilities:

Re-write test scripts based on Work Orders and change control documents

Understand clinical trial management systems and develop OQ scripts

Support multiple clinical studies applications using the IVRS system

Optical Industry

Walmart

Role: Optician

Duration: December 1997 – May 1998

Responsibilities:

Provided customer service for eyeglasses and contact lenses

Led optical lab operations and helped achieve sales of $5000/week

Contributed to the Dallas location’s #1 ranking globally

Food Industry

Pizza Hut and Chick-Fil-A (Indiana University)

Role: Customer Service Associate

Duration: December 1996 – May 1998

Responsibilities:

Provided excellent customer service by making fresh Pizzas

Ensured the Pizza given to the customers was not expired by meeting company guidelines

Prepared the Dove and other ingredients used in the formation of Pizza

Helped in the cleaning of the Utensils and cleanup of the Cafeteria

Ensured the branch Pizza sales were met providing excellent and healthy services to the customer

Ensure the team members worked in cohesion for a better work environment

EDUCATION

PGC in Optometry, UK

A.S. in Optometric Technology, USA

B.S. in Mathematics, India

Postgraduate Diploma in Computer Science, India

CERTIFICATIONS

NVIDIA’s From Basics to GenAI Practice

AWARDS & SCHOLARSHIPS

1998 Essilor Award at Indiana University

Dean’s Fee Assistance Scholarship

Dean’s List

VOLUNTEER WORK

Montco 30%

Responsibilities:

Actively attended community events to advocate for affordable housing in Bucks-Mont county

Participated in drafting housing affordability policy recommendations

Engaged with local leaders and residents to create sustainable housing solutions

Computers: Microsoft tools and diversified software applications

Contact this candidate