Beruflich Dokumente
Kultur Dokumente
• 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:-
PROFESSIONAL EXPERIENCE:-
• 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
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
• 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.