Quality Controler Resume

OBJECTIVE: To perform in proficient environment with emerging organization.

EDUCATION:

M.S. Pharmaceutical Manufacturing Engineering
Related Course: Bio-technology in API manufacturing, Validation and Regulatory Affairs in Pharmaceuticals, cGMP in Pharmaceutical Facilities Design, Pharmaceutical Finishing and Packaging, Engineering Economics and Cost Analysis, PAT in Pharmaceutical Operations, Introduction to Project Management, Quality in Pharmaceutical Manufacturing, Contemporary Concepts of Validation, regulations and compliance.

B. Pharm.
Academic Projects: Manufacturing process and formulation of Capsule Shell and tablets
Assigned as Project Engineer preparing IQ, OQ protocols and SOP's for the machines used during manufacturing of the pharmaceutical product.
Swab sampling using TOC count Unit for Cleaning Validation (CIP).

WORK EXPERIENCE:

Confidential, Gandhidham, Gujarat India (Jan 2006-Jan 2008)

Received training in Pharmaceutical Production, Quality Control, Quality Assurance
Performed various quality control tests including raw material classification, in-process and finished product quality control tests and documented procedures and standard techniques involved in tests.
Responsible for writing, reviewingandapproving Validation Master Plans, User Requirements Specs, Functional Requirements Specs,andIQ/OQ/PQ protocols. Coordinate validation activities for multiple validation projects andperform CSV Risk assessments
Worked onCIPcleaning validation systems. Writing protocols for cleaning studies using swab sampling technique. Also executing protocolsand preparing summary reports
Worked with R & D scientists to perform formulations of tablets and capsules, suspensions, pre formulation studies, immediate release and extended release formulations, different types of coatings
Performed the routine analytical tests using HPLC, GC, TLC, IR, Dissolution, Bioassay, ELISA, Protein purification, Auto Dissolution, pH Meter, UV-Vis Spectrophotometer, Polari meter under FDA regulatory environment

SKILLS:

Knowledge of the 21 CFR 11 for Electronic Record and 21 CFR 210/211 for the Good Manufacturing Process for finished dosage form along with ICH Guidelines and QSR Regulations.
Thorough working knowledge of quality systems methods and practices(DOE, FMEA, Control plans, Lean Manufacturing Concept, DMAIC, FTA, Root Cause Analysis, CAPA, etc).
Lab Skills: Performed regular Quality Control tests on Pharmaceutical products, Various Formulations for Tablet(Wet Granulation),Capsule and Sterile formulations, RollarCompaction,validation of the machines used during the operation, Cleaning validation(CIP/SIP). Performed HPLC/TLC, GC,IR methodology to detect compounds present in samples and assay it. Swab sampling by using TOC count unit for cleaning validation.
Computer: Microsoft Excel, Word, Power Point, Minitab 15, Spreadsheets, MS project
Languages: Fluent in English, Hindi and Gujarati
People Skills: Team player, experience in both group and individual presentations and projects. Extensive travel allowed exposure to a wide variety of cultures and people. Broadened technical skill set through on the job training including problem solving abilities. Improved on organizational, communication and networking skills by performing well in the corporate world.

AREA OF INTREST: Quality Control in pharmaceuticals, Pharmaceutical Validation Engineering, Analytical Chemist

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