Office Clinical Research

Pavithralakshmi Gopalsamy

***, ******* ****, ***********, ******

Telephone: 647-***-****

Email: ******@*****.***

OBJECTIVE:

Seeking a challenging role within the Pharmaceutical manufacturing industry as a Pharmaceutical manufacturing technologist, where I can utilise my education knowledge and experience. Willing to relocate.

PROFILE:

Diploma in Pharmaceutical Manufacturing Technology.

Familiar in pharmaceutical process and handling equipment’s.

Knowledge of GMP, SOP’s, SWP’s, MSDS and WHIMS.

Proficient in setup, operation, dismantling, cleaning and sanitizing the equipment.

A highly motivated professional.

Reliable, Flexible, quick learner and committed to continuous learning.

Effective time management and able to multi task.

Exceptional in mathematical skills and ability to work with accuracy.

Skilled in documentation, data management as per SOP’s and GMP requirements.

A confident communicator who enjoys leading, motivating and supervising a dynamic team.

Possesses a keen eye for detail and is meticulous in ensuring outstanding levels of customer service.

Ability to work well independently and make responsible and accountable decision.

Proficient in English written/oral

Can speak Hindi and Tamil.

Knowledge in MS office

Basic Microsoft Office experience (Word/Outlook/Excel/Power Point)

Able to manage multiple priorities

SKILLS AND ACCOMPLISHMENTS :

Pharmaceutical Manufacturing Skills

Equipment

Successfully set-up, operated, disassembled, and cleaned equipment such as V-blender, High Shear Mixture, Planetary Mixture, Granulator, Tray Dryer, B2 Tablet Press

Solved basic problems (troubleshooting) and performed adjustments according to specification parameters

Granulation

Performed pre-dispensing activities such as Bulk Density, Tap density, Carr’s index, Porosity, Potency adjustment and Batch scale up

Prepared batch folder and maintained documentation for all steps of the granulation process

Conducted all wet granulation processing steps by following SOPs and in compliance with GMP

Cleaned production area and machinery including detachable parts according to SOPs and safety procedures

Wrote SOPs for the operating and cleaning of equipment as well as production area.

Compression

Set-up, maintained and operated a multiple station of tablet press machine

Compressed tablets meeting pre-set specifications

Handled and maintained tooling according to SOP

Preformed inline ( weight variation, hardness, thickness ) and in-process ( friability, disintegration, and uniformity of dosage unit) tests on compressed tablet.

Coating

Prepared different aqueous and non-aqueous polymeric coating solution

Formulated film coated tablets using conventional coating system

Capsulation

Working knowledge of different filling methods / mechanisms and equipment

WORKING EXPERIENCE IN RELATED FIELDS

Clinical Research/Documentation Coordinator, Max Neeman Intl, New Delhi, India Dec2010 - April2013

.

Manage, analyze, implement and verify DCFs submitted through the Trial DCF system

Manage and update on DM Documentation Files (DMSF) on on-going basis

as per update schedule.

Scanning and indexing the CRF forms and creating working copies for

internal DM team.

Manage and update CRF Trackers on On-going basis during the trial period.

Assist in responding to the issues from the Client, Data Managers and site

staff.

Knowledge of study activities, protocol updates, data requirements.

Train new associates to the department.

Experience providing direct administrative support to multiple physicians

Work closely with site staff and DM staff and prepared documents during Study Audits and other study

Hello meeting.

Enter data and check for accuracy and completeness.

Work within a busy office environment, and support office teams in order to ensure the smooth running of day-to- day activities. Communicate clearly with work colleagues using emails etc.

Ability to work under pressure with attention to detail

Ability to perform duties in a professional and courteous manner and produce high quality work while meeting deadline

Maintain relationships with senior leaders to ensure to facilitate the flow of information are being followed up.

Implement and maintain the office standard procedure.

EDUCATION:

Diploma in Pharmaceutical Manufacturing Technology, Oxford collage of Business and Technology, Toronto, Canada, 2016.

Bachelors of Commerce (computer application), Bharathidasan University, Tamilnadu, India, 2009.

FURTHER SKILLS:

Diploma in office assisting (DOA) Bharathidasan University, Tamilnadu, India, 2007

Diploma in MS Programmers (DMS) Bharathidasan University, Tamilnadu, India, 2008

Status in Canada: Upon Request

Reference: Upon Request

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