R D Health Safety

E-Mail ***********.**@*****.***

Phone 267-***-****

Location Philadelphia PA 19116

CORE COMPETENCIES

Quality Assurance Pharmaceutical

DEA Regulation Knowledge

Collections & recovery

Portfolio Management

Challenging Stance

MIS

Training

Customer Service & Customer

Complaint Management

Strategic Alliance & Analytical

Techniques

Relationship / Team Management

EDUCATION

Bachelor of Computer Science (Hons), from

Aptech, New Delhi, India

Elements of Banking from Bahrain Institute

of Banking & Finance (BIBF)

ACCOMPLISHMENTS

Awarded Certificate of Merit in recognition

of Outstanding Performance in H1, 2011

Awarded the Employee of the Year 2005,

best performance in Attrition Control

Awarded the ACE OF CARDS, 2004 in

Standard Chartered Bank, Bahrain.

COMPUTER SKILLS

• Microsoft Excel, Word Document,

Adobe Acrobat and Power Point,

CV-SHIJI THOMAS

SUMMARY

An Astute Professional holding a rich experience of over 15 years with exceptional People-Management, Teamwork & Project-Management Skills to thrive in a fast-paced, results-oriented business environment.

Track compendial changes, implementation plans and deadliness; prepare, update and maintain methods and specification; process change control request, prepare documents for submission and maintain spreadsheet Empower calculations in a timely manner according to FDA, OSHA, EPA and DEA.

Controls over Process and Policies of the department.

Functional experience in Quality Assurance and Debt Management

Adhering to Credit Policy Requirements thereby minimizing credit losses and frauds.

WORK EXPERIENCE

KVK Tech. INC USA Philadelphia.

Document Control Specialist Department Quality Assurance since October 2021 till Date.

Essential Duties and Key Responsibilities:

• Follow cGMP (current Good Manufacturing Practices). GLP 21CFR211.22, 21CFR211.28 and 21CFR211.170.

• Follow all DEA ( Drug Enforcement Agency) regulations per Laboratory SOPs.

• Process Change request to reflect the changes in the system.

• Review and follow SOP’s.

• Track and assist with implementation of compendial changes.

• Prepare documents for Regulatory submission as required.

• Maintenance of Departmental Training Manuals.

• Prepare and issue maintenance/ calibration schedule for Quality Control Instruments.

• Periodic purge of document.

• Document retrieval and Support for FDA and any other customer inspections.

• Documents to be issued or retrieved within the expected timelines.

• Prepare Label organize and maintain files.

• Comply with FDA guidelines/ Company Policies of Data Integrity PREVIOUS EXPERIENCES

March 2016 – September 2021 Documents clearance Customs – Sea, Land and Air. Aramex, Bahrain

Jan 2015 – Feb 2016 Quality Assurance Officer – Collections, Standard Chartered Bank, Bahrain

Nov 2012 – Dec 2014 Collections Operations Support, Standard Chartered Bank, Bahrain

Jan 2006 – Oct 2012 Officer Tele-collections & DIP Coordinator, Standard Chartered Bank, Bahrain

Nov 2003 – Dec 2005 Officer – Attrition Control Unit, Standard Chartered Bank, Bahrain

Contact this candidate