Ravikumar Rampa

Directed Bioassay and analytical departments to ensure optimal performance.

Planning and execution of RM, PM, in-process, and finished product samples testing of Antisera samples to release with in SLA.

• Review of Standard Operating Procedures, Standard Testing Procedures, AMD, AMV, and associated reports.

Review of validated analytical methods according to established protocols.

• Executed stability protocols and studies to meet regulatory requirements.
• Prepared and harmonized specifications, COAs, and test methods per pharmacopoeias and regulations.
• Verified QC lab daily for compliance with regulatory standards, including log book checks and HPLC audit trails.
• Managed training and guidance for analysts in executing analytical tests as needed.

· Preparation of Analytical method validation protocols and execution as per written protocol

· Preparation and review of stability protocols and executing the study.

· Preparation and harmonizing of product Specifications, COA’s and Test Methods as per Pharmacopoeias and regulatory norms for various regulatory bodies.

· Daily Verification of QC lab for compliance with regulatory requirements like Log book verification, HPLC related audit trails, on- line Documents.

· Handling of internal and external audits.

· Responsible to ensure and provide required training and guidance and support to all analysts for execution analytical tests (as and when required).

· Responsible for review, tracking and timely closure of QMS events.

· Involved in Out of Specifications (OOS), deviations, change controls and failure investigations in coordination with QA.

· Preparation of investigation reports, risk assessment for change management, Corrective and Preventive Actions plans.

· Actively involved in various Regulatory and Customer audits.

Responsible for providing functional support to cross-functional teams and participating in the quality review meetings.

· Responsible to ensure Data Integrity in analytical department.

• Joined startup as deputy manager, overseeing general SOPs and study protocol preparation.
• Contributed to establishment of operational procedures in a greenfield environment.

• Team leader for the vaccine testing group of influenza, typhoid Vi polysaccharide conjugate, diphtheria, tetanus, pertussis, Haemophilus influenzae type B, and hepatitis B.

Planning and execution of the day-to-day activities to release the samples on time.

To review Standard Operating Procedures, Standard Testing Procedures, AMD, AMV, and their reports.

Preparation of analytical method validation protocols and execution as per the written protocol.

Preparation and review of stability protocols, and executing the study.

Actively involved in various regulatory and customer audits.

Involved in Out of Specifications (OOS), deviations, change controls, and failure investigations in coordination with QA.

• Analysis of in-house and finished product samples of diphtheria, tetanus, pertussis, and hepatitis B samples.
• Timely withdrawal of stability samples, testing, and release on time.
• Reporting the results to the department HOD.