16 Cottage Street apt 5 Jersey City, NJ 07306 Phone# 551.689 5181KINJAL PATEL kinjalcpatel@aol.com. PROFESSIONAL SUMMARY:

Obtain and keep a good working knowledge, assist in performing routine, preventative, and unscheduled maintenance on the production equipment.

Expertise in pharmaceuticals and biotechnology consulting, quality assurance, quality control management, CGMP compliance, process validation, technology transfer, cleaning validation, particulate matter control and visual inspection, aseptic process design.

Knowledge of contemporary production practice and service including integration of laws and regulations. Extensive knowledge regarding parenterals, oral solid dosage forms, HVAC Systems, environmental control systems,

sterilization processes, clean in place, lyophilization, blow fill seal technology, barrier isolation technology, product sample analysis, raw material analysis, product stability, and API manufacturer audit.

Excellent analytical, decision-making, problem solving, presentation and management skills with the ability to organize activities in fast speedy team environment.

Good Communication skills to communicate well with technical & non-technical people, engineers, managers and as well as with customers.

Ambitious self-starter with get-it-done attitude who strives for results and performs well under pressure.

EDUCATION:-

Master of science in Pharmaceutical manufacturing Expected graduation Dec 2009

Stevens institute of technology Hoboken NJ USA GPA: 3.3

Bachelor of Pharmacy Dec 2007 Kle’s college of pharmacy, India

Result: First class with distinction

PROFESSIONAL EXPERIENCE:- Lincoln pharmaceutical ltd Ahmadabad, Gujarat India QA/QC technician 01/07 to 08/07

Prepared Standard operating procedures and general working instructions for all instruments. Prepared Design qualification and other qualification for new instruments.

Ensured that all documentations as per ISO and FDA requirements. Testing of Dosage forms, API, Raw materials, Intermediates and In-process samples. Performed GMP/GLP compliance in the respective areas of Quality control Department.

Analyzed the quality assurance system and made recommendations for improvements. These were incorporated into the current quality assurance system. Managed a team of 6 people; assigning them

tasks, and motivating them to meet deadlines. Examined equipment in the factory to check that it met the company standards. Investigated new equipment installed

in the factory to make sure that it would comply with quality assurance procedures

Amrut pharmaceutical Karnataka India Tablet and capsules manufacturing department 12/05 to 12/06 Assistant production manager

Worked within a small team (manufacturing, filling or packaging) performing the various stages of pharmaceutical production as defined by Good Manufacturing Practice, the Quality Manual and Standard Operating Procedures.

Worked in a controlled environment, carrying out aseptic procedures using sophisticated equipment to manufacture process.

Handled and operated manufacturing equipments for the production of tablets. Prepared and complete all documentation accurately, legibly and in a timely manner. Reviewed finished product for accuracy and uniformity. Performed routine shift checks and document appropriately. Maintained complete and accurate documentation of activities to support product disposition. Attended continuing education and training programs which were relevant to the post and personal development plan.

SKILLS:-

Lab Skills: Analysis of different chemical compounds, titrations, Preparation of chemical solutions, Chromatography, UV Spectroscopy, chromatography, microbiological assays, Identification and tests of Organic and inorganic Compounds, Determination the effects of drugs on animals and plants. Technical Skills:

Microsoft office package: Microsoft Word, Microsoft Excel, Microsoft power point and Microsoft outlook express. Web Tools and Internet: Intranet, Internet Explorer 7.0, and Netscape 4.7/ 6.2, Mozilla Firefox. Operating system: MS Windows 98/2000/NT/XP/VISTA. Database: Microsoft Access

PRESENTATIONS:-

Presented Paper on Application of process analytical technologies in crystallization process. Presented Project on Good Manufacturing issues in the Pharmaceutical facilities. Presented project on API facilities in Pharmaceutical manufacturing. Presented Term paper on Validation of Bioprocess technology

EXTRA CURRICULAR ACTIVITIES :

Served as a coordinator of 2nd International Symposium on Drug Discovery and Process Research (DDPR-2006), Belgaum, Karnataka, India Date: 10th – 12th Feb’ 2006

Served as chief coordinator of 2nd global congress on cosmetic technologies theme: emerging trends in technologies and standard in cosmetics. in Feb. 2004

Active Member of International Society of Pharmaceutical Engineering.