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Executive Document Control

Location:
Menomonee Falls, Wisconsin, United States
Posted:
July 17, 2018

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Resume:

Objective:

Zest and Zeal to associate with a challenging work that would enable me to prove my endeavor, innovative ideas which will be complementary for the future development of the organization.

Educational Qualification:

Master’s Degree in Chemistry at Scott Christian College, Nagercoil, India from

2006 to 2008.

Bachelor’s Degree in Chemistry at Women’s Christian College, Nagercoil, India from 2003 to 2006.

Technical Qualification:

Post Graduate Diploma in Computer applications.

Core Competencies:

Experience in Quality Control, Research & Development and

Water Lab environments.

Good skills in maintaining professional relationship with all levels of staff.

Strong understanding of Good Laboratory Practices.

Professional Work Experience:

1.Orchid Research and Development Center

Sholinganallur, Chennai.

Documentation Executive

Years of Service: Feb-2011 to May-2012

Orchid is a vertically integrated company spanning the entire pharmaceutical value chain from discovery to delivery with established credentials in research, manufacturing and marketing. I was actively working in R&D department as a Documentation executive with good understanding of Laboratory practices and delivered quality deliverables.

Responsibilities:

Preparation of Plant Implementation Report(PIR), Provisional Process Document(PPD) and Technology Development Report(TDR).

Preparation and tracking up of Planning, Extension, Completion, and Holding of projects in a timely manner.

Preparation of Monthly quality report and Annual quality report for all the projects.

Work with R&D staff and provide support in the compilation and submission of records.

Preparation of documents required for ISO audit and for internal audit conducted by safety department.

Preparation and submission of required documents to Regulatory.

Manage local submission tracking and document control activities.

Conduct weekly review meeting with the higher officials.

Assist in gathering information from patents.

2.Shasun Chemicals and Drugs

Cuddalore

Documentation Executive

Years of Service: Mar-2009 to Jan-2011

Shasun manufactures generic pharmaceutical drugs and sells active pharmaceutical ingredients (APIs), intermediates and finished product. It is a forwardly integrated company as it combines its API’s and formulation capabilities, thus providing a one stop solution. I was working as a Documentation Executive in the QC department.

Responsibilities:

Preparation of Specification, Standard testing procedure, Standard operating procedure and Protocol in the sections of Raw material, Intermediate and Finished product.

Change specifications as per customer requirement and ensure the changes in compliance with regulatory spec.

Respond to inquiries from regulatory and timely submission in accordance with customer requirements.

Generate templates for inclusion in the procedure.

Maintain company’s change control system for compliance documentation.

Support the implementation of document control process at the site.

Document Revision, Distribution, Obsolescence and Retention activities.

Support FDA, internal safety audits.

3.Sargam Labs Pvt Ltd

Ramapuram, Chennai

Trainee Chemist: Water Lab

Dec-2008 to Feb-2009

Responsibilities:

Testing of water samples.

Follow SOP and experimental guidelines to ensure samples comply with established specifications.

Record in notebook daily and prepares data for weekly group meetings.

I hereby declare that the information furnished above are true and correct to the best of my knowledge and belief.

Place:

Date:

Signature

(S. MEENA)



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