Quality Control Development

Thomas John

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

Phone Home: 845-***-**** Cell: 914-***-****

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

OBJECTIVE:

. Seeking a Management position in a highly energetic Quality

Assurance/Quality Control or Research and Development environment with

opportunities to use my strong analytical, technical and management

skills to contribute to the success of the organization.

QUALIFICATION SUMMARY:

. Have 18 years of professional experience in pharmaceutical industry

laboratory in diversified areas and roles. I am an expertise and

analytical minded chemist with extensive experience in analytical

activities in various branches namely raw material, finished product,

stability and analytical R&D environment. Familiar with usage of all

chemical laboratory equipment. I have excellent management and

organization skills and by this I manage and train a team of chemists

and carry out various operations and experiments successfully in a

chemical laboratory. I have vast experience working efficiently and

effectively in a high pressure environment. I am an excellent team

player, technical leader and have excellent communication and writing

skills. Familiar with compliance requirements within cGMP, safety and

regulatory environments.

WORK EXPERIENCE:

TEVA Pharmaceuticals

Pomona, NY 10970

Quality Control Technical Group Leader

December 2011- Present

. Manage, lead, schedule and train chemists in a GMP environment.

. Track metrics and ensure that the team is meeting the department

goals.

. Foster morale and team work.

. Conduct training on test methods.

. Provide technical guidance and support to new product development.

. Implement test method transfers to receiving laboratories.

. Provide scientific and technical expertise to projects.

. Routinely mentor chemists who perform complicated experiments.

. Provide technical helps to chemists in times of difficulty in

troubleshooting the instruments and take care that the whole process

is carried out efficiently and effectively on time to meet the

business needs.

. Develop analytical staff to ensure accurate and reliable data are

generated to comply with QA programs and FDA requirements.

. Direct investigation teams and design testing protocols to resolve

analytical, quality or production problems.

. Manage the instrument calibration and analytical reference standard

programs.

. Review and approve specification sheet, methods, and write method

transfer protocols and reports.

. Perform out of specifications investigations by ensuring accuracy and

integrity of data.

. Review and approve the raw materials and finished products in LIMS.

. Manage the analytical method development and transfer programs to

support new product introductions by ensuring accurate analytical

procedures are established for routine use in the QC Laboratories.

. Represent the department during audits, meetings, and teleconferences

regarding technical and analytical issues.

. Provide responses to FDA deficiency letters and audit observations.

. Identify and resolve technical problems on a timely basis to avoid

inaccurate assessments and make recommendations to senior management.

. Prepare technical reports, standard operating procedures, product

specifications, analytical methods.

Abon Pharmaceutical LLC

140 Legrand Ave

Northvale, NJ

Manager (Analytical Research & Development)

Sept. 2010- Dec. 2011

. Managed a team of five scientists in research and development

. Participated as analytical representative on cross-functional

project teams with representative from other departments (API

sourcing, Formulation Development, Regulatory, Process Development

- Project Management) to accomplish business objectives (ANDA

filing of pharmaceutical finished product in solid dosage forms and

injectables)

. Designed, supervised, implemented and ensured that analytical

methods (assay, related compound, dissolution, identification and

particle size, residual solvents and cleaning validation) are

developed, validated and transferred for a variety of APIs and drug

products

. Organized and delivered effective, on-time analytical support to

early formulation development and alternate source API candidates.

. Organized API and finished product release testing, process

validation, stability data generation, evaluation and interpreting.

. Provided guidance to the team members in scientific and cGMP

matters to accomplish tasks that are scientifically sound and

cost/time effective.

. Analyzed and evaluated analytical data.

. Reviewed and determined the acceptance of analytical work in terms

of accuracy, consistency and integrity in compliance with FDA and

ICH guidelines as well as company SOPs

. Carried out critical experiments and studies in support of

regulatory submissions.

. Wrote new SOPs, specifications, standard testing procedures for the

analytical research and development laboratory.

TEVA / BARR Pharmaceuticals

Pomona, NY 10970

Quality Control Technical Group Leader

March. 2007- Sept. 2010

. Managed, lead, scheduled and trained chemists in a GMP environment.

. Tracked metrics and ensure that the team is meeting the department

goals.

. Fostered morale and team work.

. Conducted training on test methods.

. Provided technical guidance and support to new product development.

. Implemented test method transfers to receiving laboratories.

. Provided scientific and technical expertise to projects.

. Routinely designed and mentored chemists who perform complicated

experiments.

. Provided guidance and procedures to follow for new method development.

. Provided technical helps to chemists in times of difficulty in

troubleshooting the instruments and took care that the whole process

is carried out efficiently and effectively on time to meet the

business needs.

. Reviewed and approved specification sheet, methods, and write method

transfer protocols and reports.

. Performed out of specifications investigations by ensuring accuracy

and integrity of data.

. Reviewed and approved the raw materials and finished products in LIMS.

Chemist

Nov. 1999- Jan. 2007

. Performed routine testing of raw materials, finished products,

stability samples and in-house standard qualifications.

. Performed routine testing of impurities, assay, content uniformity,

dissolution, dissolution profile, residual solvents, particle size and

cleaning validation utilizing HPLC, GC, UV/VIS Spectrophotometer, TLC,

KF, FTIR and other advanced laboratory instrumentations.

. Performed routine and complex wet chemistry analysis and particle size

measurements using USP and EP procedures.

. Developed new particle size methods for AR&D using Malvern Mastersizer

X and 2000.

. Good knowledge of USP, EP, cGMP, and GLP and FDA regulations.

. Documented and interpreted test results, prepared test reports and

submitted on time to immediate supervisor for review to meet

deadlines.

. Communicated Out of Specification/Out of Trend results to management

when necessary.

. Provided assistance in OOS investigations by ensuring accuracy

/integrity of data.

. Participated and managed method transfer, data reviewing as well as

routine instrumentation calibration.

. Maintained and kept up-to-date SOPs, cGMP and safety manual

documentation.

. Always followed safety practices and maintained as #1 priority.

QA Associate

Aug. 1996- Nov. 1999

. Performed physical inspection on raw materials and other requirements

related to product release including batch record review and line

clearance.

. Revised and wrote Standard Operating Procedures as necessary.

. Performed follow up on corrective actions from quality audits.

. Implemented and reviewed quality assurance procedures for compliance

with FDA and GMP guidelines.

. Assisted new product development projects by providing other

analytical services.

. Performed work in a safe manner adhering to gowning and Personnel

Protective Equipment procedures.

EDUCATION:

Bachelor of Science; Major: Chemical Engineering

Manhattan College of Engineering, Riverdale Ave, NY.

Dec. 1995.

Master in Science; Major: Analytical Chemistry

Mahatma Gandhi University, Kerala, India.

May 1986.

Computer Skills: Microsoft Office (Word, Excel and Power Point), LIMS and

Track Wise.

References will provide upon request.

Contact this candidate