Saravanakumar S Email & Phone Number

Tamil Nadu, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Bengaluru, Karnataka, India

Competent with leadership and Operation experience in pharma API/ bulk drug manufacturing industries, skills in Quality Assurance, Quality Control, R&D Process development and Production area.Good knowledge & experience in the US FDA CFR21, EU EDQM,AFSSAPS,TGA and the ICH regulations & standards.Extensive experience in ISO 9001 Implementation, problem.

Maharastra

• Coordination with Senior Group Leaders/Scientists whenever launching/pipeline of new molecules and verify PDR/Technology Transfer.
• Assist to Head-QA for regulatory activities like DMF’s.
• Prepare/Review of Process development report and Analytical development lab document.
• Prepare /Review of Process Validation, Analytical Validation, Cleaning Validation protocols and reports.
• Experimental studies, and user trails conducted in pilot plant data interpretation and… Show more
• Experimental studies, and user trails conducted in pilot plant data interpretation and verifying.

Hosur

• I have successfully faced Afssaps, ISO 9001: 2008,WHO-GMP audits and customer GMP audits viz, Lonza,Syngenta, etc.
• Ensure manufacturing is carried out as per cGMP and effectiveness of Quality system.
• Day to Day interaction with Production & Quality Control dept. for releasing finished products to market as per the specification & customer requirement.
• Handling of Change control, Deviation & OOS for its completion and closer with proper justification & supporting… Show more I have successfully faced Afssaps, ISO 9001: 2008,WHO-GMP audits and customer GMP audits viz.
• Handling of Change control, Deviation & OOS for its completion and closer with proper justification & supporting documents.
• Data Review (Protocols, Instrument calibration and usage Records).

Chennai

• Analysis as well as documentation of API and Bulk Raw Materials, Inprocess, Intermediate, Finished Goods samples,Stability Products as well as Holding Time Study Products.
• Preparation, analysis as well as documentation of Working Standards.
• Determination of Physical Property and Wet analysis.
• Calibration of analytical instruments and their documentation.