Quality control, validation, Method transffer, method development,ICH,

Vijaya Venkat #**, Goreing Street Cambridge, ON N*T 2E8

Home: Tel: 519-***-**** Cell: 226-***-****

E-mail: *************@*****.***

Objective:

A challenging position in R & D or Quality control, where in my education, leadership, analytical technical skill & varied experience will be utilized to its best, for the success of the organization and to my career.

Highlights of Experience

Represented R&D and provided technical expertise on local and global project teams:

• Engaged team members in regular discussions on performance targets and project

execution and time lines

• Strengthened global relationships through participation on taskforces

• Communicated R&D requirements and timelines on cross-functional product launch teams.

• Partnered with Regulatory to develop submission strategies for new/altered products.

• Implemented process improvement utilizing process excellence/lean.

Utilized technical expertise and demonstrated leadership abilities

• Lead weekly planning meetings and provided direction on changing project priorities.

• Involved in group performance discussions.

• Expanded familiarity with other department functions through launch taskforce participation.

• Received training in Project Management and lead a companywide product launch team.

• Directed problem solving activities and approved results for laboratory investigations.

• Participated in the creation and review of departmental SOPs.

Developed and validated analytical test methods for raw materials, finished product testing

• Analyzed accelerated stability, process development and process validation samples (HPLC, GC, UPLC).

• Expert in handling all analytical instruments.

• Coordination of analytical activities for key projects including

- Development, validation and transfer of analytical methods

- Development and execution of accelerated stability programs

- Execution of process development and validation batch testing

- Analytical data and document review

- Task force representation

• Provide technical support to other departments with respect to analytical issues

Investigate new technologies

• Maintain the lab in accordance with current SOP's, GMP's, GLP's, ICH, FDA

• Demonstrated commitment and leadership within the department.

• Excellent oral and written communication skills. Prepared technical reports.

• Performed method validation, prepared method protocols and technical Reports.

• Punctual, methodical and positive attitude towards colleagues and meeting deadlines

Vijaya Venkat #19, Goreing Street Cambridge, ON N1T 2E8

Home: Tel: 519-***-**** Cell: 226-***-****

E-mail: *************@*****.***

______________________________________________________________________________________

• Accurate and result oriented.

• Self-motivated, goal oriented, quick/eager to learn any concepts and /or

• procedures that may enhance the company productivity and profitability.

• Good in Resource planning and job allocation to team members.

• Provided training on usage of analytical instruments.

Experience & Skills

• Performed extensive research into similar products/methods available in

literature to ensure the most appropriate methods, developed and validated

• Conducted experiments and documented results, performed method development and method validation

• Authored protocols for analytical validations

• Supported and lead analytical transfers and method meetings

• Performed routine and non-routine chemical and physical testing of products in support of analytical method transfer, validation and stability studies

• Participated analytical on Global Project Teams

• Independently plan and performed analytical tasks according to priorities assigned by Manager

• Trained peers on laboratory methods, techniques and equipment operation

• Troubleshooted instrument and product issues in consultation with internal and external technical resources

• Managed 1-2 small projects with guidance of a Project Manager Handled and help solved technical challenges based on experience and technical skills.

Employment History

• Senior Research Analyst- McNeil Consumer Health, Guelph, ON, Research & Development June 2007-Febuary 2012

-Responsible for conducting method development and method validation for new products using HPLC, GC and other instruments.

-Conducted regular long term stability as per the requirements

-Performed method transfers as per requirements

-Conducted training sessions for the use of instruments

• Chemist-I - R & D Analytical Support - Apotex Pharmaceutical , Brantford,

ON, November 2001- May 2007

-Developed impurity methods for new API

-Executed preliminary validation for the methods developed

-Coordinated lab activities to help the lab supervisor

-Maintained documentation for the projects

• Excel Industries Ltd., Mumbai, India – prior to 2001

-Developed methods for new products

-Coordinated lab activities with the corporate needs

-Responsible for finished product release

-Responsible for analytical activities of other manufacturing sites

Education

• MBA-Wilfrid Laurier University, Waterloo, ON, Canada

• Ph.D (Chemistry) – Indian Institute of Technology, Bombay.

• M.Sc (Chemistry) – Indian Institute of Technology, Bombay.

Vijaya Venkat #19, Goreing Street Cambridge, ON N1T 2E8

Home: Tel: 519-***-**** Cell: 226-***-****

E-mail: *************@*****.***

_____________________________________________________________________________

• DSM (Postgraduate Diploma in System Management) – Jamnalal Bajaj

Management Institute, Bombay

Additional skills

• Excellent presentation and communication skills

• Very good team player and like to work in teams

• Worked with third party /contract laboratories for completing projects

• Always helped team members in method development work and in trouble shooting.

• Participated in kaizens.

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