JITENDRA RANE

To work in an organization that provides an opportunity to explore my capacity & provide an environment conductive for personal & career development in the dynamic world of Pharmaceutical Organization.

B. Pharmacy, from North Maharashtra University in 2006. About 16 years of experience in Quality Control. Good knowledge of Handling OOS, OOT, Incidences and QMS activities. Experience in Different Sections of Quality Control, including API, Raw Material, Finished Product and Stability Sections for formulations like Tablets (Uncoated and Coated), Effervescent Tablets & Granules, Capsules (Hard), Pellets, Soft Gelatin Capsules, Suppositories and Oral Paste (Veterinary). Highly competent in handling HPLC with Chromeleon software. Direct exposure in multiple USFDA, MHRA, WHO, TGA, ANVISA and other MOH and Partner / Customer audits. Excellent understanding of GMP, GDP and GLP.

• Member of the core Quality Control team, which cleared last two USFDA Audits, including one surprise audit, with zero ‘Form 483’ issues.
• Currently working as Raw material section head.

• HPLC System – Make Agilent HP Chem-Station-1100/1200 Series, Shimadzu Class-VP LC 2010 / 2010CHT Series, Dionex Ultimate 3000 Series with Chromeleon software.
• Dissolution Testers – Electro lab & LABINDIA.
• FTNIR.
• KF Autotitrator
• I.R. Moisture Analyzer.
• Tablet, Suppositories Hardness Tester.
• Tablet Friability Tester.
• Disintegration Time Apparatus.
• Calibration of HPLC, Dissolution Tester
• Documentation – Preparation and Review

Ensure smooth operations of department by planning work to ensure release in timely manner. Monitor activities in SAP and PAS|X. Planning & Monitoring activities of Raw Materials. OOS, OOT, Incidences Investigation. Ensure compliance to the requirement of GLP, Help Team Members to overcome challenges, Maintain cGMP, GLP, GDP, Regulatory and Audit Compliance, and Improvement on existing System. Unit Operations, Self Inspection (Both Inter and Intra unit).

• Marathi
• English
• Hindi

• Expected Salary: About Rs 30,00,000 PA (Negotiable)
• Relocation: Willingness to both Domestic and International
• Date of Birth: 11/27/84
• Gender: Male
• Nationality: Indian
• Marital Status: Married